Regulatory Coordinator Resume Samples

The Guide To Resume Tailoring

Guide the recruiter to the conclusion that you are the best candidate for the regulatory coordinator job. It’s actually very simple. Tailor your resume by picking relevant responsibilities from the examples below and then add your accomplishments. This way, you can position yourself in the best way to get hired.

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Create a Resume in Minutes with Professional Resume Templates

CHOOSE THE BEST TEMPLATE - Choose from 15 Leading Templates. No need to think about design details.

USE PRE-WRITTEN BULLET POINTS - Select from thousands of pre-written bullet points.

SAVE YOUR DOCUMENTS IN PDF FILES - Instantly download in PDF format or share a custom link.

Create a Resume in Minutes

A Huels

Aleen

Huels

37503 Bergnaum Trail

Phoenix

+1 (555) 214 3182

37503 Bergnaum Trail

Phoenix

Phone

p +1 (555) 214 3182

Experience Experience

Los Angeles, CA

Regulatory Coordinator

Los Angeles, CA

Crona, Padberg and Watsica

Los Angeles, CA

Regulatory Coordinator

May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality
Assists in training, oversight and mentoring of research assistants. Assists in developing and documenting research education programs for clinical staff
Manage and work closely with Regulatory Assistant to ensure all Burberry beauty products are registered on time
Assists with preparation of grant applications and management of awarded contracts. Works with OSP and GCA to oversee budgetary expenses
Review registration dossiers created by Regulatory Assistant prior to approval
Recommends and implements regulatory process improvements to managers, PIs, and other study personnel
Assist with strategic account management

New York, NY

Research Regulatory Coordinator

New York, NY

Hackett-Oberbrunner

New York, NY

Research Regulatory Coordinator

Manages departmental regulatory aspects for clinical trial and research activities
Provides reporting of all regulatory activities to department leadership
Assists in formulating departmental policies and guidelines
Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process
Serves as the site regulatory contact for sponsored projects and assists with all site initiation and monitoring visits
Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, biosketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs
Collaborates with departmental staff and faculty to develop and complete necessary documentation for continuing renewals, amendments, and modifications, including the writing of consents, querying of systems to determine enrollment, and review of data safety monitoring reports

present

Los Angeles, CA

Clinical Regulatory Coordinator / Specialist

Los Angeles, CA

Bosco, Tillman and Gleason

present

Los Angeles, CA

Clinical Regulatory Coordinator / Specialist

present

Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply
Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified
Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings
Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews
Demonstrate a working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance
Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities
Create, review and revise all functional group SOP's

Education Education

Bachelor’s Degree in Paralegal Studies

Virginia Commonwealth University

Bachelor’s Degree in Paralegal Studies

Skills Skills

Strong attention to detail, good organizational skills and the ability to prioritize with changing situations
Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines
Ability to handle confidential information in a professional manner
Detailed oriented and highly self-motivated
Supply chain knowledge & international logistics knowledge
Excellent interpersonal skills including excellent verbal and written communication skills
Good knowledge of food product development and processes
Attention to Detail: Consistently displays accuracy and attention to detail
Strong attention to detail
Ability to deal with sensitive, confidential and regulatory matters

Create a Resume in Minutes

15 Regulatory Coordinator resume templates

Read our complete resume writing guides

Remediation Office Regulatory Coordinator Resume Examples & Samples

BA/BS Degree
8+ years experience in the financial services industry
8+ years experience in IT
Problem-solver, presenting options with impact, pros, and cons, with a can do attitude
An effective communicator (written and verbal) at all levels, with strong relationship building skills and can manage relationships between local teams
Proactive, goal-driven
Knowledge of financial industry regulations around records and book keeping a plus
Knowledge of SharePoint 2010 a plus
The ideal candidate will ensure that all activities and duties are carried out in full compliance with regulatory requirements, Barclays Operational Risk Framework and internal Barclays Policies and Standards

Regulatory Coordinator Resume Examples & Samples

Implement all International registration activities onto Coptis with accuracy and accountability
Provide reports on new product launches for the business to understand timings for documentation and samples for all new product launches
Work closely alongside regulatory technologists in order to ensure they put in place PIFs and any other documentation that’s required for International compliance and registration
Working with the Company’s international distributors to provide information and data that is needed to ensure compliance in other territories
Registering all new products on the CPNP
Keep up to date with legal requirements
Track the timings of the regulatory technologists activities to ensure samples and documentation are available to submit to customer operations to meet the new product critical paths
Preparing for NPD meetings for any requests related to international registration
Gain a thorough understanding of OTC products regulatory requirements
Assisting with all aspects of compliance management to ensure all new products meet required standards and documentation is maintained
Tracking the receipt of new product samples, and how these are distributed within the business
Take responsibility and accountability for the accuracy of registration dossiers to meet distributer requests
Review registration dossiers created by Regulatory administrator prior to approval
Manage and work closely with regulatory administrator to ensure all Burberry beauty products are registered on time
Continuously improve and propose ways to reduce the time to authorise, legalise and turnaround registration documentation
The regulatory coordinator will create international registration dossiers through Coptis
Coordinate with Regulatory technologists and Customer operations teams to ensure registration samples and documentation are tracked to meet launch timings
Track all documents submitted to third parties for legalisations
Ensure registration licences are received and expiration dates tracked

Compliance Regulatory Coordinator Resume Examples & Samples

Ensure identification of regulatory changes, determining applicability, monitoring implementation, assessment on controls associated with changes
Actively coordination of the Regulatory Change Management Operating Model for new regulations or changes to existing regulations
Communicate, escalate and report the changes and related action plans through working groups, governance forums and escalation paths
Coordinate the tracking process to GFB regulatory examinations, events, interactions, commitments, enforcement actions and their proper management in the Regulatory Exam Tracking System (RET)
Oversee applicable national and international laws and provisions for Mexico/LatAm countries
Leading participation in the Regulatory Control Matrix (RCM) global system project and their governance processes
Clearly define the agreements arisen in the RCM Governance Working Groups, ensuring effective oversight of the regulatory discussed items
Establish a professional relationship with internal/external stakeholders and proactively represent Regulatory Compliance as required
Early identification and assessment of compliance and regulatory risk
Bachelor’s degree in Law
Master’s degree is a very valuable plus
Laws, regulations and corporate policies implementation experience for at least 8 years
Experience on Regulatory Change Management Process Flow
Understanding of Legal framework and identification of Legal risks related to banks and financial institutions
Knowledge of the main laws and regulations for the financial and banking sector in Mexico
Experience in Compliance and Control matters is a valuable plus
Strong organizational and Regulatory Change Management experience
Excellent analytical, organization, communication, facilitation, negotiation and influencing skills with stakeholders
Ability to multitask and manage multiple regulatory project deliverables
Shows technical and analytical skills, very good follow-through on problem resolution and attention to detail; demonstrate the ability to extract and synthesize data, determine trends and make appropriate risk assessments based on facts and data
Must be a team player, very self-motivated and able to manage and prioritize workload with minimal supervision
Demonstrate sound judgment and strong decision-making skills
Strong performance record with a history of increased responsibility, and task / project delivery
Has proven abilities in taking responsibility for permanently providing high quality deliverables according to strict timetables
Experience in managing teams. Thus should be the area VP back-up
Model and motivate others to take initiative and use intuitive thinking
Demonstrate ability to manage situations in complex and dynamic environments; structure solutions to key issues and be able to work on multiple assignments at the same time
Candidates should have at least 8 years of diversified financial experience, ideally including experience in Regulatory, Control, Compliance or related fields; preferably within Citi knowledge of Citi's businesses, products and policies
Must be an articulate and effective communicator, both orally and in writing, with an energetic, charismatic and approachable style. Present self in a confident and professional manner
Strong interpersonal skills for interfacing with all levels of internal and external teams. Proven ability to interact with senior management
Proficient with use of MS (Power Point, Word, Excel) and ability to navigate and analyse data
Has the ability to gain an understand Corporate and product-specific policies/control environment, as well as key regulatory requirements

Regulatory Coordinator Resume Examples & Samples

Attend required clinical research, Clinical Research Coordinator (CRC) and departmental staff meetings
Participate in and complete training designated and/or required by CRU, IRB, DOCR, etc
Effectively manage your workload, seeking help when needed
Communicate frequently with your manager, keeping them up-to-date on your work and issues as they arise
You will work closely with your manager to implement departmental & Duke Policy and initiatives
Adherence to core work hours; time off requests will be submitted to your manager per departmental & Duke Policy
Patient care is our primary mission
When the unexpected happens you may be called upon to provide coverage outside your core work hours
Know and comply with the regulations, rules and Standard Operating Procedures for your department, Duke Medical Center, School of Medicine, OncCRU and the Duke Office of Clinical Research
Comply with Duke’s rules, regulations and responsibilities as noted in The Duke Employee Handbook and on the Duke HR website
Completion of an allied health degree (e.g., Respiratory Therapy, Radiologic Technology, Licensed Practical Nurse) or Associates degree in Clinical Trials Research related curriculum plus a minimum of three years healthcare, clinical and/or research experience
Completion of a master's degree in Public Health, Health Administration or a related area with no additional experience
Completion of a bachelor's degree plus a minimum of two years closely related clinical and/or research experience.Valid US driver's license required.Professional NC Medical License, when appropriate RAPS, ACRP, CCRC, CCRP, or SoCRA, is a plus
Excellent written, oral and conversational communication skills to effectively work with diverse groups
Ability to analyze, evaluate multiple solutions and solve complex problems using well developed critical & analytical thinking skills
Excellent time management skills needed to prioritize among many competing priorities
Attention to detail needed to operate accurately and effectively in the regulatory environment
Mastery of Microsoft Office, especially Word and Excel, and computer based information systems including eIRB and Complion

Regulatory Coordinator Resume Examples & Samples

Sponsor-funded regulatory
Adult bone marrow transplant and hematologic malignancy diseases
Consent development and IRB submissions/correspondence
Registration and results reporting in Clinicaltrials.gov
FDA submissions for Investigator Initiated Trials
Mastery of Microsoft Office, especially Word and Excel, multiple electronic databases and computer based information systems including eIRB and Microsoft Access

Regulatory Coordinator Resume Examples & Samples

Review and analyze financial reports and other relevant data to ensure compliance with FINRA and SEC rules and regulations
Understand the regulatory risks of the products offered by and business activities of assigned member firms
Identify member firms' potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business
Review and analyze complaints, trends, registration data and other relevant data
Provide FINRA management with current firm information and assist FINRA management in resolving problem situations
Act as a liaison with assigned member firms, provide interpretations of FINRA rules, SEC rules and other applicable regulations, and assist member firms in conducting business within regulatory guidelines
Prepare risk-based examination planning packages of assigned member firms, conduct planning meetings and participate in member firm examinations
Review, analyze, and communicate examination findings to member firms' senior management
Evaluate firm responses to examination reports to determine if corrective action is satisfactory and if further regulatory action is warranted
Analyze and evaluate new products to determine compliance with established rules and regulation
Review and analyze membership applications for the financial/operational/sales practices status of applicants
Train or mentor newly hired coordinators; advise and assist other coordinators in monitoring and analyzing assigned member firms
Participate in planning examinations of assigned member firms
Attend exam exit meetings, interpretive discussions and meetings with member firms
Bachelor's degree in Finance, Accounting, Business Administration or a related discipline
A minimum of 3 accounting classes
Directly related experience in a regulatory, compliance or investigative role in securities is highly preferred
Excellent interpersonal, written and verbal communication skills and computer proficiency are essential
Applicants must achieve an acceptable rating on a pre-employment assessment of writing skills

Regulatory Coordinator Resume Examples & Samples

Develop the necessary skills and knowledge by participating in programs combining self-paced learning (both print-based and computer-based, On-the-Job Training (OJT) and classroom instruction, when available. Much of the training comes from hands on experience performing various tasks and reviews under the supervision and guidance of a senior staff member
Review and analyze financial reports, trends, registration information and other relevant data to ensure compliance with FINRA, SEC and other applicable rules and regulations, including RSA client exchanges’ rules
Provide FINRA management with current firm information. Play an active role in resolving problem situations for assigned firms
Act as a liaison with assigned firms. Provide guidance related to applicable rules and regulations. Assist assigned firms in conducting business within regulatory guidelines
Understand the regulatory risks related to business activities and products being offered by assigned firms
With moderate supervision from management, identify assigned firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansion of business
With moderate supervision, prepare risk-based examination planning packages of assigned firms, actively participate in examination strategy meetings with examination staff and participate in the examination as appropriate. For example, attend the examination initial meeting, exit meeting, interpretive discussions and meetings with firm personnel, as appropriate
Review examination findings prior to issuing the final examination report to assigned firms’ senior management
Along with examination staff and examination and surveillance management personnel, evaluate firms’ responses to examination reports for satisfactory corrective action and help determine whether further action is required. Respond to firms in writing when responses are inadequate in order to request additional information
With moderate supervision, review and analyze membership applications for the financial/operational/sales practice status of applicants
Prepare and distribute daily monitoring reports issued by the department
Bachelor’s Degree in Accounting, Finance or Business Administration preferred with a minimum of nine credits in accounting
Three years of experience directly related to securities regulation, compliance or in an investigative role is highly preferred. (Master’s Degree in Accounting or Finance can be considered towards experience.)
Ability to analyze assigned firms’ financial, operational and sales practice conditions for FINRA and SEC rule compliance is essential

Regulatory Coordinator Resume Examples & Samples

Bachelor's degree (BA, BS) in life sciences, nursing, or other related discipline is required
0-1 years of related research experience or research specific training. Fundamental knowledge of the conduct of clinical trials is preferred
Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills
Demonstrated organization and time management/prioritization skills with the ability to work independently are required
Must be proficient in the use of computers, Microsoft applications and databases
Requires experience with medical terminology

Regulatory Coordinator Resume Examples & Samples

Conduct continuous real-time risk identification of assigned member firms. Show proficiency in prioritizing risk through an understanding of firm business activities, the risks associated with those business activities and the controls in place to mitigate those risks, with minimal guidance and supervision
Ongoing surveillance of assigned firms against material appropriate risks – considering relevant sales practice, business conduct and financial/operational risks
Maintain an understanding of each risk in our risk hierarchy and how each applies to the assigned member firms working under minimal supervision
Working under minimal supervision, identify member firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business. Identify and recommend resolution to problem situations
Review and analyze complaints, trends, registration data and other relevant data for high risk and complex firms to identify potential problematic activity and provide FINRA management with current firm information and assist in resolving problem situations
Provide guidance of FINRA, SEC and other rules to assist member organizations in conducting business within regulatory guidelines
Attend exam exit meetings, engage in interpretive discussions and conduct outreach meetings with member firms
Manage his/her own time to ensure it is used effectively across the program
Train, coach, and mentor surveillance staff members, including cross-training participants and new coordinators; advise and assist other coordinators in monitoring and analyzing assigned member firms
Exhibit excellent judgment, decision making and strategic thinking skills
Champion and initiate collaboration with examination staff, managers and other departments to analyze, communicate and make recommendations with respect to regulatory intelligence
Take a leadership role in special projects, surveys, committee assignments and technology initiatives

Regulatory Coordinator Resume Examples & Samples

Review and analyze financial reports, trends, registration information and other relevant data to ensure compliance with FINRA, SECA and other applicable rules and regulations, including RSA client exchanges’ rules
With limited supervision, identify assigned firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business
Provide FINRA management with current firm information and actively assist in resolving problem situations for assigned firms
With limited supervision, prepare risk-based examination planning packages of assigned firms and actively participate in examination strategy meetings with examination staff and participate in the examination as appropriate. For example, attend the examination initial meeting, exit meeting, interpretative discussions and meetings with firm personnel, as appropriate
Review examination findings prior to issuing the final examination report to firms’ senior management
Along with examination staff and examination and surveillance management personnel, evaluate firms’ responses to examination reports for satisfactory corrective action and help determine whether further regulatory action is required. Respond to firms in writing when responses are inadequate in order to request additional information
Maintain a comprehensive understanding of the regulatory risks related to business activities and products being offered by assigned firms
With limited supervision, review and analyze membership applications for the financial/operational/sales practices status of applicants.Prepare and distribute daily monitoring reports issued by the department
Four years of experience directly related to securities regulation, compliance or in an investigative role is highly preferred. (Master’s Degree in Accounting or Finance can be considered towards experience.)
Ability to analyze assigned firms’ financial, operational and sales practices conditions for FINRA and SEA rule compliance is essential

Regulatory Coordinator Resume Examples & Samples

Conduct continuous real-time risk identification of assigned member firms. Show competency in prioritizing risk, through an understanding of firm business activities, the risks associated with those business activities and the controls in place to mitigate those risks, with moderate guidance and supervision
Maintain an understanding of each risk in our risk hierarchy and how each applies to the assigned member firms working under moderate supervision
Working under moderate supervision, identify member firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business. Identify and recommend resolution to problem situations
Review and analyze complaints, trends, registration data and other relevant data for member firms to identify potential problematic activity and provide FINRA management with current firm information and assist in resolving problem situations
Attend exam exit meetings, engage in interpretive discussions and conduct outreach meetings with member firms working under moderate supervision
Collaborate with examination staff, managers and other departments to analyze, communicate and make recommendations with respect to regulatory intelligence
Participate in special projects, surveys, committee assignments and technology initiatives

Product Regulatory Coordinator Resume Examples & Samples

Fluent in local English
Accurate keyboard skills (documents and data entry)
Good literacy and numeracy skills
Competence in the use of Microsoft Office
LI-SS

Regulatory Coordinator Resume Examples & Samples

Conduct continuous real-time risk identification of assigned member firms. Working knowledge in prioritizing risk, through an understanding of firm business activities, the risks associated with those business activities and the controls in place to mitigate those risks, with direct guidance and supervision
Maintain an understanding of each risk in our risk hierarchy and how each applies to the assigned member firms working under direct guidance and supervision
Identify member firms’ potential financial or operational difficulties as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business. Identify and recommend resolution to problem situations
Actively participate in internal and external meetings on firms or examinations

Regulatory Coordinator Resume Examples & Samples

Coordinating and facilitating IRB initial submissions and annual continuation for LCCC protocols, amendments, progress reports, final reports
Liaison with the Principal Investigators, and the Director, of Clinical Research and Clinical Research Committee to track, prioritize, and report regulatory status of all adult Oncology trials
Submitting and maintaining annual approval for Investigational New Drug (IND) applications to the Food and Drug Administration (FDA) for Investigator Initiated Trials
Preparing and editing of Informed Consent Documents Maintain paper and electronic essential regulatory documents
Preparing for and host FDA and sponsor audits, works with CRMO QA Manager on compliance of regulatory documents
Providing instruction and feedback to investigators, nursing coordinators, and administrative staff in submission and review of research protocols, continuations, terminations, and safety reporting to the IRB

Regulatory Coordinator Resume Examples & Samples

Provides investigator guidance: develops and maintains all operational functions that support IND/IDE activities for the TIC including IND/IDE consultation; regulatory support; training and education; development of IND/IDE-related policies, procedures, guidances, templates, and tools
Develops and reports upon performance metrics for the program
Reviews, develops and submits applications to FDA as needed to support sponsor-investigator INDs and IDEs including but not limited to pre-INDs, initial INDs and IDEs, amendments, supplements, safety reports and annual reports
Provides guidance to sponsor-investigators and study teams in the development of their submissions to FDA, including single patient and compassionate use requests (EIND)
Reviews essential documents as needed for regulatory submission including but not limited to initial and amended protocols and any FDA required forms
Maintains trial master files for INDs and IDEs and may conduct QA audits of files on an on-going basis
Serves as liaison with the FDA as appropriate; assists with scheduling, coordinating, preparing, and attending FDA meetings; responsible for the preparation and oversight of FDA audits
Develops, reviews, and maintains SOPs related to IND-IDEs
Develops, reviews, and maintains templates, tools, and guidance documents
Assists monitoring team and provides review of on-going FDA monitoring reports as needed
Assists with internal and external audits; prepares corrective and preventive actions, if necessary
Attends IND-IDE related TIC meetings as required. May involve some travel
Maintains current knowledge of regulatory environment, especially changes to regulations and guidance documents that are applicable to sponsor-investigator research
Creates and delivers IND-IDE trainings, presentations, and other educational materials and opportunities; may evaluate external training to benefit the research activities
Participates in process review and development of innovations relating to IND-IDE applications, processing and other activities
Performs functions that ensure compliance with institutional policies, state and federal regulations, and requirements of funding agencies
Participates as assigned on working groups both locally and nationally
Reviews essential documents as needed for regulatory submission including, but not limited to, initial and amended protocols and any FDA required forms

Clinical Research Regulatory Coordinator Resume Examples & Samples

The individual must be a self-directed, flexible, conscientious and detail-oriented professional who can quickly adapt to a variety of situations
Have an in-depth working knowledge of IRB requirements, FDA regulations, Good Clinical Practice, and ICH guidelines for the conduct of clinical trials is a plus
Technical competency in interpretation and application of regulations
Familiarity with medical and scientific terminology
Excellent written, verbal and presentation skills
Advanced level skills with Microsoft Office applications
Experience with the internal BRAIN IRB submission process a plus

Research & Regulatory Coordinator Resume Examples & Samples

Completes and manages the regulatory documents of the research program and timely submits all documents to the Institutional Review Board and the study Sponsors. Independently tracks time sensitive documents for renewals and auditing of protocols keeping within the Federal guidelines. Coordinates correspondence and queries between the Institutional Review Board and the Sponsors
Creates informed consent documents that are protocol specific under the Methodist Healthcare System Institutional Review Board and the Sponsor requirements
Tracks all patients enrolled on clinical trials and submits billing forms for each patient as they reach study milestones, maintains tracking tools and coordinates all billing submissions to the finance department. Tracks all study payments and verifies milestones with the clinical trial budget. Maintains and tracks Investigator agreements, Business Associate Agreements, Data Use Agreements are all in place prior to releasing regulatory hold on trials to the clinical staff
Obtains follow up on off site patient serious adverse events and files these timely to the IRB. Provides trending reports to the Research Coordinator and Principal Investigator on a monthly basis of all serious Adverse Events that are occurring at other sites participating in multicenter clinical trials. Provides written feedback to Sponsors of IRB notifications
Maintains all regulatory files for each trial assigned by maintaining accurate filing and recording of regulatory information. Coordinates Monitor visits with the research team and the CRA. Conducts the site visit and provides all regulatory information and answers all regulatory queries. Coordinates all pre-study and site selection visits along with the Research Nurse. Maintains a log of all visitors requesting access to the department after visitor identity verification
Composes correspondence with the sponsors, physicians, committees and prepares reports as requested. Coordinates all research audits by the FDA and independently contracted auditors by collecting all study information and arranging for Investigators, Sponsors and Administrative support. Maintains research committee meetings and agendas

Regulatory Coordinator Resume Examples & Samples

High school diploma or equivalent required. Post-secondary education or training in business related field preferred
Minimum of two (2) years experience as clerical support required with at least four (4) years experience preferred
Strong computer and software skills required. Ability to use current software including word processing, spreadsheets, presentation/power point and data base systems
Ability to type 30 - 50 words per minute with a high level of accuracy
Ability to use and maintain standard office equipment to include copiers, fax machines, and other methods of electronic communications
Ability to meet multiple deadlines with effective time management
Ability to communicate effectively with all members of staff, visitors and associates
Demonstrated knowledge of customer service skills when responding to questions and other inquiries from internal and external customers
Able to perform duties with minimal supervision
Ability to forecast needs; set priorities
Must demonstrate strong organizational skills
Ability to handle confidential information in a professional manner

Audit & Regulatory Coordinator Resume Examples & Samples

Acting as a point of contact for cyber security related regulatory surveys, questionnaires, inspections and related preparation work for internal and external IT audit engagements
Provide oversight to ensure timely response on regulatory / audit requests for the Americas
Act as central point of contact for global TSS projects having an impact on America’s specific requirements
Establish and maintain close working relationships within the global TSS teams (e.g. audit, project management, engineering, operations, etc.), Americas IT Risk and regional management
Bachelor's Degree in Computing, Information Systems Management or related discipline
Minimum 7 years of experience in IT, preferable in IT Risk or IT Audit
Experience in running audit, risk and working with regulators
Sound understanding of current regulatory landscape in Americas
CISSP, CISM, CISA, CRISC or equivalent preferred
Excellent organizational, problem solving, social and operating skills
Proactive in engaging IT partners
Maturity and presence in negotiating with senior partners
Solid written and communication skills are mandatory for the role
Good planning and project management skills
Committed and determined self-starter and able to work independently

Regional Risk Regulatory Coordinator Resume Examples & Samples

To centralize the APAC local regulatory requirements under the Risk Function scope of responsibility
To coordinate and prepare Risk Function contribution/input to answer these requirements
To provide Risk APAC Management as well as participants to the Local Regulatory Coordination committee with aclear and comprehensive vision of all exchanges with local APAC regulators, pertaining to risk management
To Coordinate and prepare Risk contribution/input to answer these requests, while ensuring consistency with Head Office guidelines in terms of information disclosure and consistency across the region

HR Regulatory Coordinator Resume Examples & Samples

High school diploma or GED equivalent
Minimum of two (2) years experience in Human Resources Generalist or Human Resources clerical support role
Must have excellent written and oral communication skills and the ability to multi-task and prioritize in a deadline-oriented environment
Must have strong interpersonal and customer service skills and sensitivity dealing with confidential information
Must be detail-oriented, extremely organized with the ability to learn new programs and procedures quickly
Must be proficient on Microsoft Word, Excel and PowerPoint. Knowledge of HRIS systems preferred
Ability to set priorities and forecast needs

Regulatory Coordinator Resume Examples & Samples

Reviews import and export documentation for correct values, classifications & tariff codes
Ensure compliance with customs rules and regulations for import & export operations
Submit Permits/Licenses through Ventanilla Unica
Monitoring customs clearance performance of customs brokers, freight forwarders & carriers
Ensure tariff classification, valuation, country of origin, and trade preference knowledge to process import & export shipments
Knowledge and experience of import/export Trade Compliance procedures and regulations
Strong attention to detail, good organizational skills and the ability to prioritize with changing situations
Knowledge of SAP Systems
Supply chain knowledge & international logistics knowledge
Experience in Chemical industry or similar
2 years or more

Quality / Regulatory Coordinator Resume Examples & Samples

HS Diploma, GED or equivalent experience, preferred
1+ years experience in related field, preferred
Works on routine assignments that require basic problem resolution

Internal Audit Regulatory Coordinator Internal Audit GF Resume Examples & Samples

Act as the central point of IA contact for all Taiwan exams of CTL and CBNA Taipei branch, the two major banking legal entities, (E.g. Examination Bureau, Central Bank, Joint Credit Information Center, Central Deposit Insurance Bureau, etc.) and in coordination with the Country Compliance and Business as needed
Manage and advise audit team in regulatory exam deliverables preparation and submission for Internal Audit including performing sanity check on accuracy and completeness
Gatekeeper to ensure local IA team compliance to specific local regulatory requirements on secrecy and confidentiality
Responsible for assigning issues raised by regulators to the relevant businesses, collation of proposed corrective action for Head of Audit review and preparing exam response letters in submission of response on behalf of the Franchise
Coordinating/facilitating the communication between businesses, audit teams and regulatory examiners in response to regulatory examiners’ questions on businesses responses or CAPs
Maintain database for tracking of adherence to local regulatory requirement to facilitate audit team to ensure that scope of upcoming audits include prior issues raised
Maintaining an inventory of all responses to regulators through utilization of the Regulatory Interaction Management System (RIMS)
Prepares regulatory required reporting for HOA review before submission (risk-based audit reports and branch examination reports in Chinese, annual audit plan, annual audit execution results, internal audit qualification, training records, Internal Control Statement, significant internal control issues, annual Joint Credit Information Center reporting, etc.). Includes personally deliver of hard copy response and supporting documents to regulators’ office where required
Familiar with local governance / reporting requirements relevant to Internal Audit set in different local regulations to be able to help HoA to prepare the Audit Committee papers as well as board meeting papers in reporting of IA execution results with adequate content on a monthly basis
Track potentially significant or high risk exams for escalation and reporting purposes, providing periodic updates to senior regional management, and also to enhance exam management protocols based on outcomes and lessons learned
Facilitate the timely and accurate entry of information in Regulatory Exam Tracker (RET) and iCAPS systems in coordination with Compliance
Experience in a related role with experience in business, functional and operational management
Strong communication skills both verbal and written and ability to interact confidently with internal clients, External Auditors and Regulators
Proven ability to execute concurrently on a portfolio of high quality deliverables according to strict timetables
BA/BS or equivalent. Related certifications (CPA, ACA, CFA, CIA, CISA or similar) are a plus
Awareness of technology applications and a good business understanding of operational activities
A self-aware, self-confident individual who has well developed listening skills, and an ability to engage a group of accomplished business unit heads who are partners to the IA audit team with regards to operational activities
Exceptional analytical skills, problem-solving and root cause analysis skills. Sound judgment and proven decision-making abilities
Strong influencing skills, a proactive and 'no surprises' approach in communicating issues and strength in sustaining independent views. This individual must be an articulate and effective communicator, both orally and in writing, with an energetic, charismatic and approachable style
Good interpersonal skills for interfacing with all levels of internal and external audit and senior management
Strong leadership skills with a proven track record in collaborating across diverse teams and making a positive impact on the organization

Senior Regulatory Coordinator Resume Examples & Samples

Determines and interprets applicable rules and regulations associated with complex clinical research studies and trials involving human subjects ensuring the protection of their safety, rights, and welfare. Guides and coordinates all associated submission, documentation, and reporting processes (new study applications, renewals, revisions, modifications, amendments, adverse events, safety reports, close-out, etc.) recommending alternatives to ensure compliance and approval
Acts as a liaison between affiliate institutions, study sponsors, study coordinators, investigators and appropriate oversight/regulatory agencies when questions, issues, problems arise regarding study status and process. Serves as a resource to the clinical research office staff on regulatory concepts
Provides guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects. Creates and ensures submission of appropriate documents associated with new projects, amendments, adverse events, informed consent, revisions etc
Assists department administrator and Manager of Research Administration in maintaining department’s research compliance program by ensuring adherence to all University policies and procedures, federal, state, and other funding agency rules and regulations. Provides guidance and training to investigators and research support staff on applicable rules and regulations. Compliance program components include, but are not limited to research safety, effort reporting, and conflict of interest reporting
Completes other duties as required
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree and three years of work, experience in a regulatory and/or medical research environment having developed a strong working knowledge of clinical research protocols
Knowledge of federal, state, and other funding agency rules and regulations
Demonstrated knowledge of University research compliance requirements
Strong computer skills to include advanced use of Word and Excel software programs
Ability to identify, research, and solve problems
Knowledge of NU research facilities and systems
Demonstrated ability to adhere to complex research protocols
Excellent communication, organization, and interpersonal skills
Exhibits energy and desire to achieve
Strong planning and problem solving skills
Ability to meet deadlines and manage competing priorities

Regulatory Coordinator Resume Examples & Samples

Collaborates with Legal, Regulatory Affairs, Marketing, Sales, Quality Assurance, Food Safety, Purchasing, plants and others to leverage regulations and ensure compliance in the marketplace
Provides regulatory guidance and answers compliance-related questions regarding new and reformulated product concepts
Collaborates to identify and provide resolution to strategic and tactical regulatory issues pertaining to food labeling
Communicates cross functionally regarding current and emerging food labeling issues and opportunities and related impact on products and product technology
Maintains up-to-date knowledge of FDA regulations and policies
Maintains up-to-date knowledge of current regulations and appropriate product technology
Prepares and submits all required label approval documents
Minimum B.S. in Food Science, Nutrition or related field required or equivalent years of experience and training
Minimum of 3 years of food industry labeling experience preferred
Knowledge of FDA regulations and requirements
Detailed oriented and highly self-motivated
Ability to research regulatory issues and provide recommendations for resolution
Ability to be persuasive, assertive while also be collaborative
Proactive and goal oriented in driving business growth
Demonstrated initiative and creativity
Excellent report writing skills
Strong interpersonal, leadership and communication skills (written and verbal)
Good knowledge of food product development and processes
Demonstrated ability to handle multiple projects simultaneously
Proficient in Microsoft Office Products required
Excellent relationship skills

Regulatory Coordinator, Immuno Resume Examples & Samples

In conjunction with Regulatory Leads, coordinate creation and approval of global regulatory plans, and transmit to internal and external experts to execute the plan
Coordinate internal alignment and approval of global submission plans; ensure those plans can be executed with internal and external resources on time
Manage, track, review regulatory deliverables from external partners in line with vendor manager
Maintain regulatory work schedules with vendors and vendor managers for assigned project using common data-points and milestones
Coordinate GRS support for HA interactions lead by regional / local liaisons
Support Regulatory Lead is the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc)
Provide support for tracking progress and resolving issues with CTA preparations and submissions and approvals
Facilitate the regulatory dossier submissions to HA (IND, CTA, BLA, NDA, etc) utilizing internal and external resources; ensure appropriate quality controls in place for compliant submissions
Coordinate preparation of response to HA questions according to a rapid response process for assigned projects
Maintain tracking data in PMC and PMR database
Coordinate regulatory communications required for regulatory actions to regional and local regulatory
Writing, reviewing signing and submission of maintenance regulatory documents for all IND/CTAs - All within group with consultation of the USL, EUL or GRTL as needed
Annual Reporting Responsibilities for regulatory owned components
Support submission of US BLA/NDA submissions, as assigned
Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary)
Working knowledge of regulatory procedures (US or other) or in a specific therapeutic area (2-3 years)
Demonstrates a high-level of self-motivation and professional commitment. (In)direct management experience of people or major projects
Ability to rapidly adapt to different issues and projects at one time. Good interpersonal skills
Comprehensive understanding of the pharmaceutical industry
Comfortable working in a fast-paced environment where speed is paramount
Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets
Ability to recognize, articulate, and accept calculated risks to make informed decisions
Willingness and ability to effectively cooperate and partner with external vendors and BMS
Develop understanding of different TAs due to assignment to different projects
Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape
Increased exposure to global and multifunctional teams
Potential development into Global Strategy function, US Liaison or other role in Regulatory Sciences

Regulatory Coordinator Resume Examples & Samples

Bachelor's degree (BA, BS) in life sciences, nursing, or other related discipline is required; 1-3 years of direct regulatory experience required
Must have intermediate / very proficient knowledge of FDA and ICH/GCP guidelines
Previous experience with clinical trials and/or research coordination required

Transfusion Medicine Regulatory Coordinator Resume Examples & Samples

Develops, implements, and maintains the Quality Management Plan, Quality Assurance Manual, and Performance Improvement Plan for the sections
Reviews and monitors quality control activities for the sections. Monitors preventative maintenance of equipment and instrument quality control. Responsible for the FDA, CAP, and AABB accreditation and regulatory programs for the section, including maintaining current licensure and submission of required annual FDA report
Adheres to regulatory, institutional, and divisional requirements and assures section remains compliant. Facilitates the preparation for regulatory agency inspections and works with section personnel on the corrective actions to meet requirements. Manages quality audits and reviews documentation of errors and accidents

Clinical Regulatory Coordinator Resume Examples & Samples

Ensure timely IRB submissions, including new research project applications, renewals, addenda, serious adverse events, project conclusions, satisfying provisos
Present new research studies to Institutional Review Board
Maintain a research database, track IRB applications, and advise investigators on the status of their protocols
Identify and track approved research protocols, including implementing established procedures to assist investigators in responding to IRB requests
Assist and write documents for research studies including but not limited to

Regulatory Coordinator Resume Examples & Samples

Monitor and evaluate the financial, operational and sales practice conditions of assigned member firms to ensure compliance with FINRA and SEC rules and regulations through the review and analysis of financial reports and other relevant data, as well as the performance of specific surveillance functions pursuant to Divisional guidelines
Conduct continuous real-time risk identification of assigned member firms
Identify member firms’ potential financial or operational difficulties, as well as monitor and evaluate mergers, acquisitions, conversions and significant expansions of business
Provide FINRA management with current firm information. Identify and recommend resolutions to problem situations
Act as a liaison with internal clients and assigned firms; provide guidance of FINRA, SEC and other rules to assist member organizations in conducting business within regulatory guidelines; run meetings with firms while under supervision and guidance
Prepare risk based examination planning packages of assigned member firms and conduct planning meetings with the examination staff under minimal supervision and guidance
Collaborate with examination staff, managers, other departments, and regulatory agencies to analyze, communicate and make recommendations with respect to regulatory intelligence
Work to ensure regulatory programs serve departmental goals and FINRA’s mission in an efficient and effective manner
Participate in developing training content; advise the Business Solutions Training Group on the technical accuracy of classroom materials
Present surveillance related matters at internal meetings and conferences
Assist in providing classroom training on technical matters for the Division’s staff, or other FINRA training programs; train less experienced regulatory coordinators
Proactively identify ideas for in-house training
Serve as a mentor and coach to less experienced staff
Bachelor’s Degree in Accounting, Finance, Economics or related field preferred with a minimum of 6 credits in Accounting; equivalent experience in a directly related securities industry position may be substituted for Bachelor’s degree
In-depth knowledge of financial and operational risks; and securities industry rules, regulations, guidelines and industry best practices
In-depth knowledge of securities products, activities of member firms and the securities industry
Minimum of five years of securities, compliance or financial regulatory experience; Master’s Degree in accounting or finance can be considered towards experience
Sound critical thinking and analytical skills; proficient in analyzing data and identifying risk; excellent judgment, decision making and strategic thinking skills
Strong time management skills

Rates & Regulatory Coordinator Resume Examples & Samples

Competency using PC applications such as Word, Outlook, Excel, PowerPoint, and Internet Explorer
Demonstrated planning and organizing skills, superior oral and written communication skills, and the ability to effectively handle multiple tasks simultaneously
Candidate must foster an inclusive work environment and respect all aspects of diversity. Successful candidate must demonstrate and value differences in others' strengths, perspectives, approaches, and personal choices
Use of SAP, i.e CATS HR
College level courses and/or degree
Proficiency with SharePoint and PSEG’s Website software
Must possess and maintain a valid driver’s license

Regulatory Coordinator Resume Examples & Samples

Master’s degree in Business or Healthcare Administration preferred
3-5 years experience in a health care setting with extensive knowledge of TJC standards, conditions of participation and health care regulatory requirements
Demonstrates self-directed work practices
Understanding of National Patient Safety Initiatives and key components of care delivery, which drive improved outcomes
Knowledge of various software applications: Decision Support Systems, MS-Excel or Lotus 123, Word, MS-Access and web based tools
Demonstrates leadership and interpersonal competencies necessary to develop, organize, motivate and coordinate groups across the organization
Excellent organizational skills with attention to detail
Ability to deal with sensitive, confidential and regulatory matters

Temporary Assistant Regulatory Coordinator Resume Examples & Samples

Must complete NU's IRB CITI training before interacting with study participants or research date & must re-certify every 3 years
Strong computer competency, to include proficiency in Microsoft Word & Excel
Professional attitude and ability

Regulatory Coordinator Resume Examples & Samples

University Degree is required; paralegal studies preferred
A minimum of five to ten years relevant regulatory or utility environment background is required
Experience with various accounting software applications would be considered a definite asset. Proficiency with MS Office is essential, with advanced Word skills
The candidate should have excellent organizational and time management skills, and strong communication skills
A background in lean six sigma methodology or another comparable process improvement methodology would be considered an asset

Regulatory Coordinator Resume Examples & Samples

Supports all aspects of regulatory compliance
Prepares regulatory documents, including consent forms for submission to research review committees
Communicates with research committees and administrative units, project sponsors and project staff to ensure accuracy of regulatory documents and submissions
Tracks study approvals and expirations to ensure uninterrupted project approval
Tracks sponsor and investigator initiated amendment notifications and submits amended protocols, summaries and consents to the Institutional Review Board (IRB), uTRAC, CMS, FDA etc
Submits study renewal applications and study progress reports to the IRB
Coordinates with study sponsor, investigator and IRB to complete study closure activities
Assists investigators and others involved in clinical research with process and policy issues and provides guidance on form preparation and submission
Recommends and implements regulatory process improvements
Maintains current knowledge of federal and institutional guidelines and requirements governing research
Maintains regulatory databases
Generates ad hoc reports as requested
Assists with data collection, reporting, and entry into EDC databases

Compliance & Regulatory Coordinator Resume Examples & Samples

Assists with the maintaining, implementation, verification and validation of the Company’s Food Safety Plan to ensure compliance to the Food Safety Modernization Act’s regulations applicable to food manufacturers.Provides back-up support for other Preventive Controls Qualified Individuals
Assists with the Company’s Corrective and Preventive Action Program.Includes assisting with root cause investigation, corrective/preventive action implementation and verification of the implemented action(s)
Provide routine reports on the status of the Program
Participates in company-wide regulatory, third-party and customer audits designated for the evaluation of Blue Diamond’s Preventive Controls, Food Safety, Food Security and Food Quality systems
Assists with the training of Company personnel and contract staffing.Training to include but not limited to Preventive Controls, HACCP, Food Safety, Food Security, Food Quality and Allergen Control
Serves as a technical resource on Production Improvement Teams; collaborates with other departments (Production, Sales, Sanitation, Planning and Scheduling) to promote food safety and quality standards
Assists with the Company’s pasteurization program to ensure adherence to the Almond Industry Pasteurization Rule; provides support to pasteurization validation studies
Assists with the implementing, maintaining, verifying and validating of the Company’s SQF System; includes HACCP, Food Safety, Food Security and Food Quality programs
Provides back-up support for SQF Practitioners and/or other SQF Practitioner Designees
This job description reflects management’s assignment of essential functions; it does not prescribe or restrict the tasks that may be assigned
3 years of administrative support experience in a production/operations environment
Intermediate to expert level of math and computer (MS Office) skills
Intermediate understanding of ERP systems (SAP preferred), FSMA (Preventive Controls), SQF Code, HACCP and GMPs
Able to present concepts and ideas to internal and external stakeholders
Able to write and interpret complex documents in a clear and concise manner
Able work independently to accomplished assigned duties and responsibilities
Able to define problems, apply solutions and verify the effectiveness of the solutions at preventing reoccurrence of the problems
Able to interpret data to ensure that the Food Safety and Food Quality expectations are being accomplished according to established procedures

Research Regulatory Coordinator Resume Examples & Samples

2 years of experience in related medical field
3 years of experience in clinical research with knowledge about the conduct of clinical research, research principles, and methodologies/study design
Master's degree in a scientific or health-related field
Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Certified Research Associate (CRA), Certified Clinical Research Professional (CCRP), Certified Clinical Research Coordinator (CCRC), or comparable within 1 year of employment
Working knowledge of basic statistics
Must demonstrate a high degree of clerical accuracy with attentiveness to detail and ability to organize data
Broad knowledge of federal regulations and regulatory requirements for conducting research with the ability to provide education and training
Self-directed and motivated to work independently toward short- and long-term goals and the ability to exercise independent judgment
Good computer skills, including working knowledge of a PC and Microsoft Office (Word, Access, Excel, and PowerPoint)
Must be able to successfully pass the Basic Windows Skill Assessment at 80% or higher rating within 30 days of date of employment
Manages departmental regulatory aspects for clinical trial and research activities
Serves as the Institutional Review Board liaison for all regulatory activities within the department
Compiles and maintains regulatory binders
Develops, maintains, utilizes, and updates all internal and external protocols, data collection sheets, spreadsheets, and databases for use in gathering and compiling information specific to each research process
Develops written consent forms for each protocol which conform to federal and institutional guidelines to provide patients, parents, or guardians with detailed summaries to enable informed decisions
Serves as the site regulatory contact for sponsored projects and assists with all site initiation and monitoring visits
Completes and maintains regulatory documents for all study personnel, including curriculum vitae, license, biosketches, financial disclosures, Form FDA 1572, confidentiality agreements, and delegation of duties logs
Develops lay summaries for each protocol which are utilized by the Institutional Review Board in the initial review process
Develops web summaries for each protocol which are utilized on the clinical trials website for public access to open protocols
Collaborates with departmental staff and faculty to develop and complete necessary documentation for continuing renewals, amendments, and modifications, including the writing of consents, querying of systems to determine enrollment, and review of data safety monitoring reports
Oversees quality monitoring and reporting activities
Supports the Manager, Program Research in the day-to-day activities of regulatory safety management for patients enrolled on research protocols
Collaborates with all departments to ensure research complies with organizational guidelines and regulatory standards
Assists in formulating departmental policies and guidelines
Assists in preparation for audit events
Ensures quality of audits as defined by the area departmental quality standards
Provides reporting of all regulatory activities to department leadership
Provides a detailed summary of all new and active protocols to facilitate the Institutional Review Board submission process
Works collaboratively with faculty and staff on all initial and ongoing protocols, amendments, and Institutional Review Board re-approvals on a monthly basis

Regulatory Coordinator Resume Examples & Samples

Responsible for assisting in the preparation of registration packages
Maintain the regulatory files and database with respect to product labels and product base labels
Responsible for administrative clerical activities including scanning, copying, mailing, maintaining office supplies, coding invoices
Help generate master labels using a standard label creation process
Supports the senior regulatory staff in their work
Develop a proficiency in the company's business management system and related applications and programs (SAP and SPX)
0 - 4 years of experience in regulatory or legal fields
Strong computer and keyboarding skills including MS Office Suite skills
Must possess interpersonal skills with the ability to work with a wide variety of internal and external business contacts
Able to work across multiple constituencies and manage multiple priorities
LI-AR

Regulatory Coordinator Resume Examples & Samples

Prepares IRB documents for local and central IRBs including the IRB application, informed consent form, study synopsis, annual renewals, and modifications
Prepares and submits FDA correspondence for investigator-initiated trials
Liaises with Investigators and Immunotherapy study team to ensure accuracy of documentation
Maintains regulatory files including IND, Investigator, Manufacturing, and Trial Master Files (Sponsor)
Collaborate with data team to extract data from study databases for scheduled and ad hoc reports for ongoing review of subject accrual data, safety data, and IND annual reports
Ensure sponsor oversight and reporting
With the research manager, coordinates monitoring and auditing visits with Clinical Research Support (CRS), industry sponsors, and third party auditors
2-3 years of clinical research regulatory coordinator experience or equivalent formal education
Reviewing IRB documentation and research protocols
Writing technical documents
Bachelor’s degree required; Master’s degree in regulatory affairs preferred
Knowledge of FDA, ICH/GCP guidelines
Clinical research related certification preferred
Advanced knowledge of MS Word and Excel

Regulatory Coordinator Resume Examples & Samples

Tracks sponsor-specific queries and resolutions. Works with Regional Regulatory Coordinators to obtain updated documents and/or resolve pending queries
Assists in processing protocol amendments and/or consent form revisions for assigned trials. Responsible for ensuring new/updated regulatory documentation meets applicable regulations and is submitted to the pharmaceutical sponsor/contract research organization, and/or FDA in a timely manner
Assists with study-related documents necessitating IRB review throughout the conduct of a trial (protocol amendments, continuing reviews, protocol deviations/exceptions)
Completes critical document collection instructions, as specified for new trials. Maintains and updates internal status log of critical and regulatory documentation completion
Maintains study-specific and site regulatory files by filing and auditing existing regulatory documentation prior to regularly scheduled monitoring visits and audits
Participates in early development meetings, conference calls, and discussions concerning the regulatory aspects of a trial in development until the trial is complete

Cancer Clinical Trials Regulatory Coordinator Resume Examples & Samples

Function as an administrative and regulatory link between the Cancer Clinical Trials Office, protocol sponsors, IRB and FDA (as applicable)
Function as primary contact with study sponsors or funding agencies throughout the study-start-up process
Prepare or obtain all required regulatory documentation for each clinical trial in preparation for study activation including but not limited to: stud-specific FDA Form 1572, program’s research license, investigator signature pages acknowledging receipt of documents, delegation of authority form, training logs, laboratory certifications and credentials, IRB documentation and membership list, authorized prescribers list and the following documents for each investigator: Financial Disclosure Form, Curriculum Vitae, Medical License, institutional Conflict of Interest Form and certifications for Good Clinical Practice, Human Subjects Protection and HIPAA
Maintain regulatory binders with the above documents as well as IRB approvals and study-related correspondence for each protocol from pre-activation through close-out, making sure to update each document as information changes or the document expires
Ensure that the Cancer Clinical Trials Office is “audit-ready” at all times, with regard to regulatory documentation
Function as liaison between the Cancer Clinical Trials Office and the BMC Clinical Trials Office with regard to institutional requirements related to clinical research
Submit and maintain current study documentation in the Clinical Trials Management System (CTMS) VelosCT from pre-activation through close-out
Register investigator-initiated interventional studies with clinicaltrials.gov and update regularly throughout the life of the study
Revise sponsor’s model informed consent form to comply with institutional requirements and obtain sponsor approval prior to submission to IRB
Obtain IRB approval for all protocol documents and protocol amendments from pre-activation through close-out utilizing various IRB electronic programs, as appropriate for each protocol. Documents include, but are not limited to the protocol, informed consent form, drug brochures, patient materials, recruitment materials, data safety monitoring reports and annual continuing review reports
Submit IRB approval documents to sponsor upon receipt
Notify IRB and study sponsor of all protocol exceptions, deviations, new information and unanticipated events
Create and maintain appropriate “note to file” documentation to clarify any aspect of the regulatory documentation that is not explicitly clear to avoid any questions in the future
Maintain current information in the National Cancer Institutes (NCI) Cancer Trials Support Unit (CTSU) web site with regard to active or inactive research staff, pharmacy staff, radiation physicists and investigators
Function as main regulatory contact between BMC and the various NCI groups including, but not limited to SWOG, NRG Oncology, the Cancer Trials Support Unit (CTSU), NCI Central IRB, AIDS Malignancy Consortium
Submit annual NCI Investigator renewal packets to the FDA for each investigator, including FDA Form 1572, Financial Disclosure Form, Supplemental Investigational Data Form and curriculum vitae. Submission must include signed originals
Submit regulatory documentation for new investigators to obtain membership in SWOG and NRG Oncology via the CTSU web site
Prepare and submit FDA Investigator New Drug (IND) applications for applicable investigator-initiated protocols
Submit to FDA Serious Adverse Event (SAE) reports, updates to FDA Form 1572, changes to protocol and annual reports for all active INDs
Maintain current certifications in Good Clinical Practice, the Protection of Human Subjects and HIPAA
Maintain awareness of all current and new regulatory requirements relating to human subject research, disseminate information to staff and investigators, and update CCTO procedures as appropriate
Participate in the monthly Scientific Review Committee to evaluate which protocols to activate at BMC
Create and/or maintain Excel or Access databases for tracking of pertinent information, as needed
Function as a liaison between the Principal Investigator, protocol sponsors, the FDA, the IRB and collaborating institutions
Serve as an educator to oncology staff, residents and fellows in the areas of FDA and IRB regulatory requirements and provide assistance in preparing protocol documents and IRB applications
Performs all other duties as assigned by Supervisor to ensure proper and efficient function of the Cancer Clinical Trials Office

Regulatory Coordinator Resume Examples & Samples

Supports all aspects of regulatory compliance. Prepares, facilitates, submits and maintains the process for accurate and timely submission of IRB applications for protocol revisions or amendments, administrative changes, changes in subject population, funding, recruitment procedures, site changes, changes in the informed consent, or dual enrollment to additional studies for IRB approved protocols as required by the federal regulations and internal policy
Facilitates and coordinates all aspects of IRB submissions. Includes evaluating the protocol changes and incorporating those changes into the informed consent form in language understandable to the participant as required by the specific revisions made to the research protocol
Tracks sponsor and investigator initiated amendment notifications and submits amended protocols, summaries and consents to the IRB

Risk & Regulatory Coordinator Resume Examples & Samples

Risk management and surgical experience preferred
Knowledge of Infection Prevention standards, Joint Commission; AAAHC, CMS, OSHA, CLIA and other applicable regulatory organizations
Must possess excellent communication skills
Must be able to prioritize, organize and multi-task

IRB Regulatory Coordinator Resume Examples & Samples

Demonstrated clinical and management ability
Demonstrated ability to handle numerous simultaneous projects, high attention to detail demonstrated in clinical and contractual settings
Ability to communicate complex technical material to physicians, other clinical Associates, and patients and their families both verbally and in writing
Ability to plan and schedule tasks and projects and to maintain control of own and other’s work flow by prioritizing projects
Responsible for assisting investigators with all IRB submission related issues to ensure they meet the requirements of federal, state and institutional regulations and policies governing human research and privacy
Comprehensive analysis and evaluation of IRB applications submitted for IRB review
Establishes, utilizes, and maintains effective communication systems within the Research Network

Quality Regulatory Coordinator Resume Examples & Samples

Experience with data collection, analysis, trending and quality reporting
Knowledge of Joint Commission; AAAHC, CMS, OSHA, CLIA and other applicable regulatory organizations
Must be a self-starter with strong organizational, communication, and interpersonal skills, and a strong work ethic and integrity

Regulatory Coordinator Resume Examples & Samples

Communication - Expresses ideas clearly and constructively (written and spoken, upward and downward, one-on-one and with groups)
Customer Service - Seeks to understand customer needs and works to exceed customer expectations (internal and external)
Professionalism - Treats others with respect; abides by the institutional values; displays a positive and cooperative attitude; adheres to the workplace Code of Conduct and compliance policies
Stewardship - Identifies efficiencies to reduce redundancy and/or elimination of tasks resulting in savings of cost, resources, and or/time
Teamwork - Works proactively and collaboratively with others to streamline work and achieve mutual goals

Regulatory Coordinator Resume Examples & Samples

Assists with the preparation and processing of Office of Radiation, Chemical & Biological Safety (ORCBS) reports and project forms, confidentiality agreements, material transfer agreements, Institutional Review Board (IRB) and/or Institutional Animal Care and Use Committee (IACUC) applications and assists with Investigational New Drug (IND) Applications / Investigational Device Exemptions (IDE) submissions and clinicaltrial.gov registrations
Provides regulatory administrative support to research investigators including preparation and continual updating of regulatory binders and/or study subject case report form binders
Maintains updated knowledge base and communicates changes in regulatory guidelines, statutes, and policies to investigators, study personnel, technicians & students
Interacts with project sponsors for preliminary site assessment including completion of questionnaires and coordination of and attendance at site visits
Facilitates the start-up, ongoing progress, and close-out of the regulatory processes for research projects
Meets with study sponsor monitors and university regulatory personnel for audits of project regulatory materials and study data; responds to queries from monitoring entities
Trains on and utilizes multiple sponsor electronic data capture programs to review study-specific regulatory, study data listings and compliance of reports for quality and accuracy
Provides support to Principal Investigators, Study Coordinators I, II, III and/or Research Assistants I, II, or III
Assist with post approval monitoring of units to ensure adequate documentation & regulatory processes at unit level
Point person to ensure completion of the Occupational Health forms
Coordinates the communication between investigators, internal departments, and external agencies & sponsors
Assists with ordering animals, chemicals and radioisotopes

Regulatory Coordinator Resume Examples & Samples

Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (NU’s IRB, sponsors (NIH, industry), government agencies (FDA), etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance
Determines compliance required documentation and drafts necessary items such as protocols, informed consent, etc. Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers
Provides guidance and training to research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects
Creates reports, summaries and analysis in regard to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance
Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials
Successful completion of a full 4-year course of study in an accredited college or university leading to a bachelor's or higher degree in a major such as computer science, information technology, or related; OR appropriate combination of education and experience
Knowledge of oncology terminology and staging; General knowledge of protocol design
Attention to Detail: Consistently displays accuracy and attention to detail
Organization: Plans, organizes and schedules in an efficient, productive manner; anticipates contingencies and pays attention to detail; targets projects or initiatives that require special attention and focuses on key tasks when faced with limited time and or resources
Strong regulatory knowledge including familiarity with Code of Federal Regulations and Good Clinical Practice Guidelines
Computer literacy in word processing database use, and file management
One year experience in research, clinical trials research, or regulatory knowledge
Communication-Oral and Written: Communicates effectively one-to-one, in small groups and in public speaking contexts; writes precise, well-organized emails, letters and proposals while using appropriate vocabulary and grammar
Research Regulations: Demonstrates knowledge of federal and state regulations governing the participation of human and animal research subjects
Team Player: Seeks to build collaboration by encouraging trust, mutual respect and shared purpose among various participants in an engagement

Regulatory Coordinator Senior Resume Examples & Samples

Eight (8) years of experience with financial planning and analysis, financial accounting or regulatory accounting. Experience with formulaic rate mechanisms, understanding of historical and projected test year concepts, cost of service fundamentals, methods of determining return on equity a plus
Experience communicating complicated business, financial, and accounting information to senior management
Experience coordinating activities across business units in order to accomplish goals
Experience with regulatory bodies that exercise influence or control over company activities
Experience with rate cases, fuel reviews, rider updates, or other regulatory proceedings
Managerial or supervisorial experience
Strong Financial acumen including Accounting and Financial Planning and Analysis
Knowledge of regulatory processes applications such as testimony, minimum filing requirement preparation and review, and strategic planning
Ability to examine and evaluate data and present alternative actions in relations to the evaluations
Knowledge of OCC, APSC, rules and regulation
Demonstrated ability to handle confidential information and material with the highest degree of professional responsibility
Effective relationship building skills. Excellent leadership abilities
High personal standards of commitment and integrity
Ability to coach and provide extensive training to internal regulatory members for workforce planning
Ability to manage multiple tasks with shifting priorities. Knowledge of the organization, processes, and customers
Effective business communication and consultation skills to communicate with all levels throughout the organization and outside professionals
Knowledge of legal research methodologies and practices and procedures of regulatory bodies
Ability to interface with and effectively communicate with all levels of leadership
Ability to coordinate a team of professionals in order to influence and attain positive results, by providing an environment of empowerment and encouraging continuous improvement

Regulatory Coordinator Resume Examples & Samples

Prepares and submits all initial, renewal, and study closure reports to the IRB, OSP and any other regulatory agencies
Tracks study approvals, updates, and expirations to ensure uninterrupted project progress
Tracks sponsor and PI-initiated amendments, submits amended protocols, summaries, and consents to the IRB
In conjunction with PI, ensures that the rights and welfare of research participants are protected in accordance with federal and institutional guidelines
Completes, audits, and maintains study records, materials, and databases to ensure compliance with study protocols, FDA, IRB, departmental, and university regulations
Tracks adverse events. Reports serious adverse events and protocol violations to IRB and sponsor
Assists PIs and other research staff with research process and policy issues, also provides regulatory process guidance and teaching
Assists with preparation of grant applications and management of awarded contracts. Works with OSP and GCA to oversee budgetary expenses
Maintains division-specific regulatory binders and tracking database
Recommends and implements regulatory process improvements to managers, PIs, and other study personnel

Regulatory Coordinator Resume Examples & Samples

Bachelor’s degree. Experience may substitute for minimum education requirements
At least 2 years of experience related to the management and conduct of oncology clinical trials in an academic setting. Working knowledge of clinical trials, Federal, State, and Local Regulations, IRB requirements, consent form and protocol development
Certification in Clinical Research is preferred
Excellent skills in time management, prioritization, and multi-tasking required. Strong organizational skills Ability to practice independently, strong verbal and written communication skills, organizational and critical judgment skills, and be able to interact effectively with co-workers and customers. Strong attention to detail. Ability to focus on task is essential
Be clearly understood by verbal communication in face-to-face encounters and by telephone. Must be able to engage in a variety of telephone and face-to-face meetings related to pending and active projects on a daily basis
Strong command of the English language, including spelling, writing, and verbalizing and ability to communicate well verbally and in writing. Must be able to read, interpret, and process large quantities of printed information
Computer skills including MS Office products, Internet, and general computer proficiency required. Must be able to master new software by utilizing available resources (other program personnel, reference manual, training classes, etc.)

Senior Regulatory Coordinator Resume Examples & Samples

Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (NU’s IRB, sponsors (NIH, industry), government agencies (FDA), etc.) to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite research while ensuring compliance. Assists junior staff in resolving such issues and problems
Determines compliance required documentation and develops necessary items such as protocols, informed consent, etc. Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers
Provides guidance and training to junior staff and research staff to ensure compliance with complex, highly specialized rules and regulations associated with clinical research studies and trials involving human subjects
Serves as a resource to the clinical research office staff on regulatory concepts
Maintains the regulatory portion of the CRO database. This includes IRB approval dates, revision dates, protocol status, and adverse event tracki
Three year's of work experience in a regulatory and/or medical research environment having developed a strong working knowledge of clinical research protocols or other relavant experience required
Strong communication, writing, and interpersonal skills
Computer literacy in word processing, database use, and file management

Clinical Regulatory Coordinator / Specialist Resume Examples & Samples

Work closely with Clinical Operations and Regulatory Affairs to ensure compliance with regulatory authorities
Act as a liaison between the Site IRBs and Clinical team to resolve regulatory queries and concerns
Prepare and assist in submission of protocol amendments, IND safety reports, consent form changes, and continuing reviews
Oversees reporting of AEs, SAEs, IND safety data, violations, deviations and submission of other study documents to support regulatory compliance, and troubleshoots processes and procedures when issues are identified
Review documentation/submissions from departments outside of Regulatory Affairs
Develop training modules consistent with organizational needs in accordance with current international GCP requirements
Perform investigation of deviations and monitoring of Corrective actions & preventive actions (CAPA) relating to non-compliance issues and findings
Create, review and revise all functional group SOP's
Maintain Trial Master Files
Demonstrate a working knowledge of internal SOP's, FDA/lCH guidelines to GCP's and regulatory compliance
Knowledge of and direct experience with Trial Master File and prior regulatory experience desirable
Fundamental knowledge of the conduct of clinical trials is preferred
Strong focus on teamwork, attention to detail, excellent organizational skills. Must have ability to prioritize, and the ability to work in a multi-task environment
Must be able to work independently
Must maintain confidentiality of information, demonstrate good decision-making and judgment
Experience Electronic Data Capture (EDC) such as Inform for clinical trials
Detail-oriented and comfortable with tight timelines
Experience with controlled clinical terminology is helpful but not required
Knowledge of and direct experience with Trial Master File and eTMF (ie.Veeva) experience and Microsoft office desirable
Bachelor's degree or higher in life sciences, health sciences, nursing, pharmacy, or other related field
0-4 years of clinical research experience in academic and/or industry settings; oncology experience strongly preferred
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply

Accreditation & Regulatory Coordinator Resume Examples & Samples

Minimum of two to three years progressively more responsible related work experience in accreditation and regulatory activities
Experience with, and understanding of key functions of hospital and medical staff departments or services
Previous Joint Commission and Centers for Medicaid and Medicare accreditation experience preferred, with a minimum of 5 years of leadership experience within a healthcare delivery system with an in depth understanding of regulatory requirements and healthcare operations
Certification as a Joint Commission Professional (CJCP) preferred

Regulatory Coordinator Resume Examples & Samples

A minimum of 2 years experience in clinical research or IRB functions
Knowledge about clinical research administration, regulatory requirements
Knowledge of key research regulations (e.g., FDA / OHRP / ORI / DHHS / NIH)
General understanding of human subject protection and Institutional Review Board regulation and operation
Computer proficient in Microsoft WORD, EXCEL, ACCESS and PowerPoint applications
Strong attention to detail and ability to adhere to policies and procedures
Effective organizational skills, effective follow-through and commitment to excellence
Strong interpersonal skills; ability to work with personnel at all levels to gather information, communicate compliance requirements and handle complex issues within an often-sensitive political environment
Ability to work collaboratively in a team environment. Must be flexible and adaptable as conditions and environment are unpredictable and change frequently. Able to track multiple projects simultaneously

Research Regulatory Coordinator Resume Examples & Samples

Some college with emphasis in health sciences, biological sciences, or related field; Bachelor’s Degree preferred
Previous research experience and/or related clinical experience desired
ACRP or SoCRA certification within one year and one week of eligibility required

Regulatory Coordinator Resume Examples & Samples

Proactive personality
Fast and flexible, focused on timely delivery and stretch targets
Ability to plan and priorities workload
Ability to work in a matrix environment
Ability to build effective relationships across teams Prior publishing/Regulatory Operations experience desired

Human Resources Regulatory Coordinator Resume Examples & Samples

Processes I-9 documentation and assists in the training process across the health system on appropriate methodology
Coordinates file audits of employee records to ensure Human Resources and department compliance, in accordance with Joint Commission and other regulatory agencies. Generates reports as needed
Provides department administrators and designees with guidance on the appropriate application of Human Resources policies and procedures
Assists with document management support
Liaise with relevant government agencies as needed

Technology Regulatory Coordinator Resume Examples & Samples

Coordinate cross-functional technology reviews for regulatory materials/updates being presented to US regulators
Attend regulatory meetings to minute from a technology perspective, with emphasis on technology discussions, actions, commitments, and follow ups
Collaborate with RMG, DCRO, and CIO RRC for consolidated GT regulatory commitment tracking and reporting

Download Regulatory Coordinator Resume Sample as Image file

Related Job Titles

Regulatory Controller Resume Sample

Regulatory Management Resume Sample

Customer Relations Coordinator Resume Sample

Conference Coordinator Resume Sample

Regulatory Scientist Resume Sample

Relationship Coordinator Resume Sample

Alumni Relations Coordinator Resume Sample

Regulatory Affairs Coordinator Resume Sample

Regulatory Operations Resume Sample

Counsel, Regulatory Resume Sample

Regulatory Strategy Resume Sample

Coordinator, Regulatory Resume Sample

Browse More

Regulatory Coordinator Resume Samples

The Guide To Resume Tailoring

Craft your perfect resume by picking job responsibilities written by professional recruiters

Pick from the thousands of curated job responsibilities used by the leading companies

Tailor your resume & cover letter with wording that best fits for each job you apply

Resume Builder

Resume Builder

15 Regulatory Coordinator resume templates

Read our complete resume writing guides

How to Tailor Your Resume

How to Make a Resume

How to Mention Achievements

Work Experience in Resume

50+ Skills to Put on a Resume

How and Why Put Hobbies

Top 22 Fonts for Your Resume

50 Best Resume Tips

200+ Action Words to Use

Internship Resume

Killer Resume Summary

Write a Resume Objective

What to Put on a Resume

How Long Should a Resume Be

The Best Resume Format

How to List Education

CV vs. Resume: The Difference

Include Contact Information

Resume Format PDF vs Word

How to Write a Student Resume

Remediation Office Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Compliance Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Product Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Clinical Research Regulatory Coordinator Resume Examples & Samples

Research & Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Audit & Regulatory Coordinator Resume Examples & Samples

Regional Risk Regulatory Coordinator Resume Examples & Samples

HR Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Quality / Regulatory Coordinator Resume Examples & Samples

Internal Audit Regulatory Coordinator Internal Audit GF Resume Examples & Samples

Senior Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator, Immuno Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Transfusion Medicine Regulatory Coordinator Resume Examples & Samples

Clinical Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Rates & Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Temporary Assistant Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Compliance & Regulatory Coordinator Resume Examples & Samples

Research Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Cancer Clinical Trials Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Risk & Regulatory Coordinator Resume Examples & Samples

IRB Regulatory Coordinator Resume Examples & Samples

Quality Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

Regulatory Coordinator Senior Resume Examples & Samples

Regulatory Coordinator Resume Examples & Samples

How to Make
a Resume

50 Best
Resume Tips

200+ Action
Words to Use

Internship
Resume