Regulatory Coordinator Job Description
Regulatory coordinator
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.
Regulatory Coordinator Duties & Responsibilities
To write an effective regulatory coordinator job description, begin by listing detailed duties, responsibilities and expectations. We have included regulatory coordinator job description templates that you can modify and use.
Sample responsibilities for this position include:
Accountable for effectively managing the tracking and reporting of regulatory findings
Ability to apply product classification for footwear
Gather and publish agenda items at least 3 days prior to any recurring meeting
Assemble presentations and upload into Sharepoint at least 3 days prior to any recurring meeting
Circulate agenda and presentations to non-regulatory staff at least 3 days prior to any meeting
Coordinate travel plans for all staff
Submit expense reports for all staff within 1 week of travel completion
Work with travel to negotiate hotel and transportation for any offsite meetings
Maintain a standard list of office supplies
Coordinate purchase of non-standard items as needed
Regulatory Coordinator Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Regulatory Coordinator
List any licenses or certifications required by the position: CITI, ACRP, CPHQ, CJCP, PMP, CPIA, GMP, RAPS, AALAS, BA
Education for Regulatory Coordinator
Typically a job would require a certain level of education.
Employers hiring for the regulatory coordinator job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Collage Degree in Education, Science, Communication, Health, Business, Associates, Healthcare, Human Relations, Nursing, Medical
Skills for Regulatory Coordinator
Desired skills for regulatory coordinator include:
Current regulations
Local policies
Regulatory guidance and
Conduct of clinical trials
Rules and regulations relating to securities
Access
Biology
Clinical sciences
Database
Equivalent combination of education and experience
Desired experience for regulatory coordinator includes:
Maintain list of all vacation and sick days for each member
Assist in budget management by monitoring invoices and purchases
Work with recurring vendors to get them set up in ASPEN so they can upload invoices and track payments on their own
Track lobbyist expenses and process quarterly lobbying disclosure reports
Develop standard list of equipment and software for all staff
Maintain list of all active consultants with key contact information
Regulatory Coordinator Examples
1
Regulatory Coordinator Job Description
Job Description Example
Our innovative and growing company is looking for a regulatory coordinator. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory coordinator
- Manages submission of all regulatory documents to the IRB, including development of informed consent forms and protocol review for complex studies involving more than minimal risk to research subjects
- Review and preparation of site informed consent forms
- Collection and maintenance of regulatory documents
- Completion of local Institutional Review Board applications and modifications
- Tracking of IRB approvals
- Completion of continuing review reporting, and
- Preparation and assistance with internal and sponsor monitoring visits
- Develop, implement and periodically review processes and policies related to compliance with these federal and state regulations
- Participate in external compliance inspections performed by state and federal regulatory personnel and periodic testing of internal compliance procedures, issue assessment and audit findings
- Review external audit findings and prepare and submit responses to the appropriate state or federal agency
Qualifications for regulatory coordinator
- At least 1 year of clinical research work in the areas of protocol management and case report form management
- Familiarity with federal regulatory requirements
- Proficiency in use of office equipment, word processing, data entry, and forms design
- Excellent communications and interpersonal skills for representing department positively in all communications
- Skills in organization, prioritization, and procedures, with the ability to manage priorities and duties with close attention to detail
- Strong computer skills preferably Microsoft Word and Excel
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Regulatory Coordinator Job Description
Job Description Example
Our growing company is looking for a regulatory coordinator. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for regulatory coordinator
- Various other duties as required to support overall regulatory functions
- Tracks new protocols through the committee system to approval, responds to committees' inquiries
- Gathers data needed to prepare and process applications for IRB review and approval
- Collaborates with the Principal Investigator (PI) in completion of application documents including all required PPHS paperwork, for approval of new clinical research trials
- Coordinates conference calls with investigators to aid in study development
- Obtains IND# for the clinical trials through correspondence with the FDA, and submission of paperwork necessary to obtain an IND#
- Collaborates with the Financial Manager on the development of the study budget (as needed)
- Updates and maintains records of protocols on clinicaltrials.gov website
- Upon protocol approval, transitions the protocol to be implemented by investigator(s), program manager(s), clinical research coordinator(s), regulatory coordinator(s), and research nurse(s)
- Organizes and conducts start-up meetings for new protocols
Qualifications for regulatory coordinator
- Organization, prioritization and procedural skills are essential, with the ability to manage priorities and duties with close attention to detail
- Must pass Collaborative Institutional Training Initiative (CITI) research protection modules within three months of hire
- Uses various systems and tools
- Demonstrated ability to research, compile and/or prepare reports, responses to proposed changes in regulations, reviews of recommendations, policies, procedures, and correspondence
- Experience reading and interpreting applicable governmental regulations applicable to federally regulated intrastate and interstate pipelines and company and/or industry publications related to pipeline reporting compliance
- Experience researching, identifying, evaluating, and prioritizing problems or situations and coordinating appropriate actions or responses
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Regulatory Coordinator Job Description
Job Description Example
Our innovative and growing company is looking to fill the role of regulatory coordinator. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory coordinator
- Manages external database subscriptions relating to the department
- Accurately reviews, enters and maintains ERP system item master product specifications or product regulatory and technical compliance specifications and test data
- Handles standard plant requests for modifications and maintenance to manufacturing facility item master engineering data or compliance testing schedules according to Technical Group Services department procedures
- Maintains department, team and other associated databases according to department procedures
- Maintains plant request files for item master or product testing
- Acts independently to manage the product regulatory and technical compliance activities of the SBU manufacturing facilities as they relate to product specifications or technical compliance with regulations
- Reviews plant item master inputs or test data for accuracy and completeness and produces regulatory compliance documentation for plants, customers and governmental agencies
- Develops schedules for regulatory testing
- Receives requests from plants, or supervisor for item master product changes in ERP systems, or for services related to product testing, specification compliance or product change requests, and processes these tasks independently according to department procedures
- Identifies requests that do not conform to department policies and elevates them to supervisor for handling
Qualifications for regulatory coordinator
- Must be proficient on Microsoft Word, Excel and PowerPoint
- 5 years of mortgage or consumer lending compliance experience
- Possesses and applies comprehensive problem solving abilities for moderately complex issues
- Experience with Encompass LOS a plus
- Customer focused experience
- Experience with various accounting software applications would be considered a definite asset
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Regulatory Coordinator Job Description
Job Description Example
Our company is searching for experienced candidates for the position of regulatory coordinator. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for regulatory coordinator
- Facilitates and coordinates all aspects of IRB submissions
- Delivering clear and up to date Management Information from the global CRC teams to the VP - BD and Ops
- Supporting the implementation of new processes to help streamline business operations
- Supporting Executive Assistants in London CRC teams with WIP Management, forward forecasting
- Working with the VP - BD and Ops to identify new methods of data management for reporting and Management Information purposes
- Assisting the CRC London teams to organize and run key internally-focused projects (such as internal technical training)
- Supporting the CRC business with research projects for campaigns, new product launches and other activities as required
- Updating the CRM system with key activities and client meetings held for reporting and Management Information purposes
- Coordination of internal and external meetings, diary management for the VP - BD and Ops
- Meets with study sponsor monitors and university regulatory personnel for audits of project regulatory materials and study data
Qualifications for regulatory coordinator
- Proficient in use of common office equipment
- Some knowledge of administrative accounting and bookkeeping practices and procedures
- Associates or Bachelor’s degree in Environmental Science & Policy or similar field strongly preferred
- Knowledge of Oasis, Oracle and Remedy software programs preferred
- 0-5 years experience in compliance preferred
- DOT hazmat knowledge
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Regulatory Coordinator Job Description
Job Description Example
Our company is growing rapidly and is searching for experienced candidates for the position of regulatory coordinator. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for regulatory coordinator
- Perform analyses and provide guidance and recommendations in support of regulatory cases and financial impact of cases before the Oklahoma Corporation Commission, Arkansas Public Service Commission, the Federal Energy Regulatory Commission or other state and federal agencies
- Research/draft testimony on behalf of the Company’s expert witnesses, covering numerous fields of expertise for regulatory proceedings, styled for the appropriate regulatory jurisdiction
- Coordinate research, analysis, workpapers, testimony and other case related work of other regulatory members and compile them into a professional package ready for filing
- Perform research and analysis needed to interpret, guide, and develop testimony and discovery request responses
- Prepare briefing material and/or communications for senior management, customer and client organizations and regulators
- Coordinate the research, analysis and interpretation of data and disseminate information and reporting to the OCC, APSC, FERC, or other government agencies
- Assists with preparation of grant applications and management of awarded contracts
- Prepare and submit start-up regulatory packets to Sponsor and IRB
- Strong focus on teamwork, attention to detail, excellent organizational skills
- 0-4 years of clinical research experience in academic and/or industry settings
Qualifications for regulatory coordinator
- Demonstrated knowledge of CMS Quality and OIG Compliance standards related to the provision of health care
- Two (2) or more years of administrative or supervisory experience
- Master’s degree in health care related field, quality or project management
- BA/BS degree, experience may substitute
- Professional demeanor, critical thinking, excellent communication and organizational skills to work with a wide audience
- Knowledge of Clinical Research and regulatory forms is preferred