Clinical Administrator Resume Samples

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SC
S Cremin
Stefanie
Cremin
8913 Jonathon Ports
Chicago
IL
+1 (555) 725 7978
8913 Jonathon Ports
Chicago
IL
Phone
p +1 (555) 725 7978
Experience Experience
Boston, MA
Clinical Administrator
Boston, MA
Smitham, Hartmann and Macejkovic
Boston, MA
Clinical Administrator
  • Leading a team of clinical and business professionals to promote outstanding clinical results, physician, patient and teammate satisfaction with the center’s services and financial performance
  • Working in collaboration with the Medical Director and surgeon partners to develop and maintain effective strategic, programmatic, and marketing plans to grow and maximize center outcomes
  • Managing the center’s financial results, including a multi-million-dollar P&L, financial controls, reporting and analysis
  • Ensuring quality outcomes, labor efficiencies, supply chain management, volume growth, revenue cycle optimization and regulatory accreditation/compliance
  • Overseeing the center’s physical assets, including the building and equipment, in compliance with local, state and federal regulations
  • Providing a comprehensive proactive admin service
  • Routinely handling all admin/secretarial duties, including setting up meetings, scheduling appointments, maintaining calendar and proactive email management for the department Director
New York, NY
Clinical Project Administrator
New York, NY
Hudson Inc
New York, NY
Clinical Project Administrator
  • Provide clerical support to the project team, work with multiple contacts (CRA, PM, Manager…)
  • Create, update, track, and maintain study-specific trial management files, tools, and systems
  • Perform other administrative duties as assigned by management
  • Perform other duties as assigned by management
  • Assist with the management of study supplies and organize shipments
  • Provide input in writing Monitoring Conventions as assigned
  • Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data
present
Chicago, IL
Senior Clinical Trials Administrator
Chicago, IL
Schuppe, DuBuque and Klein
present
Chicago, IL
Senior Clinical Trials Administrator
present
  • Assist in development of departmental training processes
  • Provide assistance to CRAs with specific tasks
  • Assist in development of departmental SOPs
  • Work in conjunction with Departmental Manager on offsite storage and retrieval projects and processes
  • Assist CTLs with preparation, handling, mailing and distribution of Clinical Trial Supplies and maintenance of tracking information
  • Assist with coordination and organization of meetings for Clinical Trial Services
  • Mentor and assist with the training of junior level staff
Education Education
Bachelor’s Degree in Independence
Bachelor’s Degree in Independence
Syracuse University
Bachelor’s Degree in Independence
Skills Skills
  • Knowledge and management of project management tools and resources
  • Ability to set priorities and handle multiple tasks simultaneously
  • Good organizational and time management skills
  • Knowledge of financial systems applications and accepted business process and practices
  • Working knowledge of word processing and spreadsheet computer software packages and financial systems
  • Ability to prioritize, plan, and execute multiple complicated and continuing contract and grant assignments in a timely manner
  • Skill in establishing and maintaining effective working relationships. Excellent oral/written communication and interpersonal skills
  • Skill in strategic and analytic thought with an ability to solve problems and make decisions
  • Fluency in French and English language
  • Aptitude for handling and reviewing numerical data
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15 Clinical Administrator resume templates

1

Senior Clinical Administrator Resume Examples & Samples

  • Analysis
  • Assessment/evaluation
  • Budget control
  • Budget development
  • Communication—written and oral skills
  • Consulting
  • Counseling
  • Interpretation of policies/analyses/trends/etc
  • Interviewing
  • Knowledge of applicable laws/policies/principles/etc
  • Mediation
  • Networking
  • Problem identification and resolution
  • Teaching/training
2

Clinical Trial Administrator Resume Examples & Samples

  • Maintains the overall accuracy of the institution’s clinical trials portfolio within the organization’s Sponsored Programs) Access Database
  • Acts as an institutional liaison between Data Doctor Office Technology Systems (DDOTS), Inc. and Christiana Care. Maintains and trains CCHS research departments on the DDOTS -CREDIT system. Provides support for system changes such as upgrades, expansions and trouble-shooting of the system
  • Develops and maintains a cost analysis computer program to allow appropriate finance tracking while ensuring compliance with CIA requirements
  • Reviews industry-sponsored clinical trials and source documents to provide guidance to research departments and staff regarding cost and feasibility of clinical trial participation
  • Develops project budgets and contract/compliance issues related to clinical trials and negotiates the budget with the industry sponsor
  • Meets individually with project managers to conduct budget feasibility assessments after thorough review of all industry-sponsored protocols
  • Negotiates and processes all Confidentiality Disclosure Agreements (CDA’s) and other agreements with industry sponsored projects
  • Serves as the direct point-of-contact for all clinical trial research departmental issues and resolves issues either directly or indirectly
  • Acts as a liaison between the Office of Sponsored Programs Clinical Trial Division, the research community, Legal department and the Institutional Review Board (IRB)
  • Collaborates with the Research Education and Compliance Manager to coordinate training sessions to the Research Enterprise, Develops education and focuses on areas that directly affect clinical trial management
  • Bachelor’s Degree in Business or Finance preferred.Minimum of 3 years of experience in sponsored programs administration preferred 2-years of Grant/Finance experience required. An equivalent combination of education and experience may be substituted
  • Knowledge of good clinical concepts and practices of all departments involved in research at Christiana
  • Experience working with and understanding industry sponsored clinical trials and protocols,
  • Knowledge of clinical research and clinical trial participant enrollment, management and follow-up
3

Dhcm Clinical Administrator Resume Examples & Samples

  • Administration and oversight of the clinical units in DHCM, coordinate work processes, implement initiatives, meet deadlines, ensure the sm ooth running and positive morale of the division, handling of issues and concerns, and proactive identification of issues and new information to be elevated
  • Attend and lead division and agency meetings/committees related to the clinical programs and activity of DHCM
  • Participation in RFP, waiver, grant writing and requirements
  • Develop and maintain relationships with community organizations, state, federal and local agencies/departments, regulatory organizations, provider representative organizations and advocacy groups
  • Prepare reports for CMS, NCQA, CDC as requested or required by regulatory agencies
  • Representing AHCCCS at public events, serving as speaker/presenter when requested related to quality or health and safety topics
  • Proficient knowledge and experience in behavioral health and/or physical health integration strategies
  • Knowledge of and experience with AHCCCS rules, regulations, program policies and procedures relating to health care project and program management
  • Strong decision making skills
  • Demonstrated ability to multi-task in a fast-paced environment where re-prioritization occurs frequently
  • Effective organizational skills to coordinate and manage a large number of programs and projects simultaneously
  • Demonstrated experience working closely in a positive manner with the Governor’s Office, other state agencies, county officials, stakeholders, health plans, etc. and strong interpersonal skills dealing with subordinates, peers, Executive Management and external contractors
  • Minimum of five years of progressive work experience in managed healthcare
  • Advanced degree in business or health care administration
  • AZ licensed Registered Nurse or a Certified Professional in Health Care Quality (CPHQ) by the National Association of Health Care Quality (NAHQ)
  • Experience with the design, development, and administration of managed health care programs with strong experience in managing, motivating, and coordinating high-level professionals
  • Knowledge of the public behavioral health systems in Arizona
4

Clinical Services Grant Administrator Resume Examples & Samples

  • Manage the receipt and tracking of invoices from vendors and / or investigative sites
  • Confirm the appropriateness of invoices by confirming underlying contract / statement of work
  • Ensure timely approval of payments from individuals within operations with the appropriate Grant of Approval
  • Determine appropriate payment terms for payment
  • Process invoices using appropriate Bristol-Myers Squibb (BMS) systems and / or coordination with outsourced / offshore service function for appropriate payment
  • Interact with sites and vendors on payment inquiries and their resolution
  • Manage end-to-end payment processes to ensure timely payment and ensure supplier discounts and rebates are achieved for BMS
  • Perform analytics and report on payment volumes and cycle-times
  • Knowledge of SAP including reporting functionality
  • Experience in financial or health sciences or related industries (pharmaceutical, hospital-based, laboratory, CRO, etc.)
  • Working knowledge of clinical trials, contracts and Scope of Work documents, Clinical Trial Management Systems and medical terminology
  • A minimum of a High School diploma is required; Associates or Bachelors degree is preferred
  • 1603592
5

Clinical Trials Administrator, / II / Senior Resume Examples & Samples

  • Maintain the paper and electronic central files ensuring efficiency, accuracy and quality
  • Upload, apply naming convention and file essential documents in electronic document management system as required for project team members
  • Support retrieval of documents
  • Ensure up to date study documents in tracking systems / document repositories
  • Perform archive procedures upon study termination: prepare copies of files as required
  • Proficient in Microsoft Office including Word/Excel/Outlook/PowerPoint
  • Proficient use of an eTMF, CTMS and / or EDC systems preferred
  • Proficient use of an offsite storage and retrieval system preferred
  • Ability to solve problems creatively
  • Ability to multi-task in a demanding and rapidly changing environment
6

Clinical Trials Grants Administrator Resume Examples & Samples

  • Two years of work related experience in grants administration inclusive of federal funding
  • Prior experience in academia is beneficial
  • CITI Certification must be obtained within first 3 months of employment
  • An advanced degree may substitute for years of experience
  • Experience in grant funding research, some writing and technical review of applications, including management of financial and legal obligatory requirements
  • Knowledge of NIH and other grant source activities standards, guidelines and requirements
  • Excellent written, oral and interpersonal communication skills. Good judgment. Flexible and service oriented
  • Excellent computer skills, particularly with spreadsheets and the web. Knowledge of financial accounting systems
  • Knowledge of MS Office programs
  • Able to produce high quality work within strict deadlines Teaching and public speaking experience preferred
7

Clinical Trial Administrator Resume Examples & Samples

  • You hold a University degree or any other relevant education
  • Minimum 1 year of an administrative experience
  • You have the team oriented personality
  • Quality mind-set with attention to details
  • You have the ability to analyze data; good communication skills
  • You are flexible and result-oriented with a ‘can-do’ attitude, able to adjust quickly to new situations in a continuously changing business environment
  • Good command of Russian and English oral and written would be a great advantage. Knowledge of medical/pharmaceutical terminology will be a plus
  • Knowledge of relevant clinical IT systemswill be an advantage, i.e. eTMF, databases created locally (e.g. «IRB_LEC_data base_CEC_Moscow.xls», «IRB_LEC_data base_Central.xls», «IRB_LEC_data base_Nord-West.xls», «IRB_LEC_data base_Ural-Siberia.xls»; «Investigators data base»)
8

Senior Clinical Trials Administrator Resume Examples & Samples

  • Maintain clinical files per SOPs, ensuring efficiency, accuracy and quality
  • Prepare, handle, distribute and file clinical documentation
  • Assist in maintaining / updating the electronic Trial Master File (eTMF)
  • Act as a central contact for the clinical team for designated TMF projects
  • Assist with coordination and organization of meetings for Clinical Trial Services
  • Provide global support for TMF and archival projects
  • Provide metric reports for management as needed
  • Participate in project team meetings
  • Mentor and assist with the training of junior level staff
  • Assist in development of departmental SOPs
  • Assist in development of departmental training processes
  • Work in conjunction with Departmental Manager on offsite storage and retrieval projects and processes
  • Enter clinical trials data into the appropriate database, if required
  • Photocopy, print and distribute documents, as needed
  • Maintain quality control procedures to ensure accurate maintenance of files
  • Assist Clinical Trial Lead (CTLs) and Clinical Research Associates (CRAs) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines
  • Assist CTLs with preparation, handling, mailing and distribution of Clinical Trial Supplies and maintenance of tracking information
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
  • Assist with coordination and organization of meetings such as Investigator and Study Coordinator meetings
  • Provide assistance to CRAs with specific tasks
  • Arrange the printing and shipping of clinical study materials to clinical sites
  • Audit / review study files periodically for accuracy and completeness
  • Duties as assigned
  • Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint)
  • Proficient in PhlexEview
  • Experience with using an offsite storage and retrieval system
9

Clinical Development Department Administrator Resume Examples & Samples

  • Provide general administrative support, including: copying, filing, telephone coverage, data entry, correspondence, document compilation and management etc
  • Be proactive in anticipating needs of the members of the department, in identifying and implementing work practices that can contribute to departmental efficiency and productivity
  • Coordinate meetings, conference calls and webinars (internal and external)
  • Manage travel arrangements for employees and external consultants
  • Manage and triage Safety email inbox
  • Manage and distribute monthly reports (internal and external)
  • Track and upload important documents
  • Maintain calendars, spreadsheets and contact database
  • Assist with organizing documents for Audit
  • Maintain important safety-related documents (Keep SUSAR spreadsheet tracker current
  • Manage vendor invoices
  • Act as the Company Receptionist on occasion, as required
10

Senior Clinical Project Administrator Resume Examples & Samples

  • Diploma – Secondary Education or equivalent
  • Minimum of four (4) years administrative experience in a corporate environment or, minimum of four (4) years Clinical Project Administrator experience
  • Demonstrated aptitude for training
  • Ability to set priorities and handle multiple tasks simultaneously
  • Ability to operate standard office equipment (e.g., fax, copier)
11

Senior Clinical Project Administrator Resume Examples & Samples

  • Coach and train junior/newly CTAs together with line manager
  • Assist line manager to train CRAs on finance policy and expenses claim system
  • This role should understand company's compliance and SHE policy, and to manage the daily activity to align with these accordingly
12

Early Clinical Development Program Administrator Resume Examples & Samples

  • Administrative support to Early Development, including but not limited to
  • Trial Master File maintenance and filing of relevant documents according to ICH-GCP and SOPs and respective archiving and electronic filing of documents
  • Perform periodic Trial Master File quality control check through course of study as defined by study team
  • Support with management of the agreement and contract execution, dispatch and tracking
  • Support with study start up activities for study management or site management (e.g. review of study specific documents {trackers and metrics} provided by CRO, maintenance of country and site feasibility trackers, etc.)
  • Assist with the preparation/collection of all study documents (e.g. protocol, CRF, forms, manuals, etc.)and presentation materials
  • Support with tracking timelines/deliverables
  • Track various program-related activities/documents such as project team calendars, monitoring
  • Knowledge of ICH-GCP and SOPs in Clinical Research and Development
  • 2-5 years’ experience in related competencies
  • Experience in early phase clinical studies
13

Clinical Quality Administrator Resume Examples & Samples

  • Lead precepting and ownership of training plans
  • Be a coach, in partnership with Regional Manager for VillageHealth Nurses
  • Meet with Regional Manager to present clinical data and discuss team - cohesive collaboration
  • Conduct boot camps / workshops for teams based on request by Regional Manager/ Program Director
  • Lead clinical improvement projects for the division or by program
  • Working with the auditors and Regional Managers to get information on the specifics and discuss with Regional Manager, to support coaching on charting
  • Closing the gap between training, quality and CQAs, i.e., gets specific feedback on what is coming from quality
  • Join teams supported for monthly homerooms
  • Facilitates initial training and provides support and mentoring to new VillageHealth Nurses (VHNs) in patient care delivery, policies, procedures, systems and reports
  • Develops course content, training materials, educational tools, and policies related to new processes in collaboration with the education team, Subject Matter Experts, and Regional Operations Managers (ROMs)
  • Oversees existing training material and updates on an ongoing basis in collaboration with the education team
  • Independently conducts audits of VHNs’ work and patient results and creates action plans as needed
  • Provides regular coaching and mentoring of team members to enhance job satisfaction and retention
  • Provides ongoing coaching and oversight to VHNs on prioritization and time management of tasks and responsibilities
  • Works with Regional Operations Manager (ROM) to analyze and maintain monthly scorecards and other related reports and creates action plans and follows up as needed for each VHN
  • Provides feedback to ROM on performance, strengths, opportunities for improvement, and development/growth potential on a monthly basis
  • Conducts site visits with assigned team members as required by outside agencies and VillageHealth internal audit processes
  • Knows and complies with
  • DaVita patient care policies and procedures
  • Standards necessary to maintain organizational accreditation (such as NCQA)
  • State or federal regulations of the Injury Prevention and Safety Training Program
  • Nursing practice acts as required by state
  • A.D.N degree from accredited school of nursing required; B.S.N. preferred
  • Current RN license in state of practice
  • Minimum of three (3) years’ experience in clinical nursing required; Five (5) years preferred; renal nursing experience preferred
  • Experience in healthcare performance coaching preferred
  • Demonstrated experience managing to data driven outcomes and process improvement
  • Experience developing and delivering training materials
  • Current CPR certification; Certified Nephrology Nurse (CNN) or Certified Case Manager (CCM) preferred
  • Current driver’s license with positive driving record required; ability to meet requirements of insurance coverage
  • Basic computer skills and proficiency in MS Word, Outlook, Excel and PowerPoint
14

Clinical Administrator Resume Examples & Samples

  • Leading a team of clinical and business professionals to promote outstanding clinical results, physician, patient and teammate satisfaction with the center’s services and financial performance
  • Working in collaboration with the Medical Director and surgeon partners to develop and maintain effective strategic, programmatic, and marketing plans to grow and maximize center outcomes
  • Managing the center’s financial results, including a multi-million-dollar P&L, financial controls, reporting and analysis
  • Ensuring quality outcomes, labor efficiencies, supply chain management, volume growth, revenue cycle optimization and regulatory accreditation/compliance
  • Overseeing the center’s physical assets, including the building and equipment, in compliance with local, state and federal regulations
  • Master's Degree in Health Administration, Business Administration, or Management preferred
  • Minimum of 5-7 years of progressively responsible financial, personnel, operations management experience in a health care setting
  • Experience in outpatient surgery center desirable but not required
15

Supervisor Clinical Administrator Resume Examples & Samples

  • This position will supervise 10-15 team members located in MN, CO, and MD
  • Will be working closely with manager to ensure team and business needs are met
  • New employee onboarding and training coordination
  • Ensure a timely acknowledgement and response to all authorization documents received providing appropriate feedback to address processing issues, including the referral process, where applicable
  • Coordinates, supervises and is accountable for the daily activities, quality, and productivity of the assigned team
  • Communicate with provider and/or office staff and/or other employees to research and verify information provided on authorization documents when appropriate using a professional, courteous and cheerful manner
  • Review with management individualized reports reflecting daily production and quality in order to accurately measure and monitor predetermined company, position and individual goals
  • Provide administrative expertise and support for the administrative team as well as acting as a liaison with the Physical Health clinical staff and other internal business partners
  • Act as a subject matter expert for client implementations and system enhancements, including job aid development and updates
  • 2 year degree, or higher (4+ years of healthcare insurance experience may be considered in place of the degree requirement)
  • 2+ years of Lead or Supervisory experience
  • Ability to multitask and meet deadlines
  • End user testing experience
  • Managed Care experience in an administrative coordination or support role
  • Experience supervising, or acting in a lead role, for remote employees
16

Clinical Quality Program Administrator Resume Examples & Samples

  • Oversees the nonclinical and/or clinical quality improvement activities/projects/tasks to implement appropriate clinical and/or nonclinical interventions to improve the quality of care for members
  • Provides oversight to assure accurate and complete quantitative analysis of clinical and nonclinical quality data and presentation of results
  • Assists with Healthcare Effectiveness Data and Information Set (HEDIS) project team activities
  • Requires a BS in health administration, nursing, psychology or related health sciences field; 3 years of health care, quality, managed care experience and data analysis experience; or any combination of education and experience, which would provide an equivalent background
  • MS in the health field (i.e. Nursing, Psychology or other health sciences related degree) preferred
  • HEDIS experience or education highly preferred
  • Project Management experience or in process preferred
  • Willing to complete Six Sigma Yellow and Green Belt training courses
  • At least one year in developing dashboards experience preferred
  • Willing to travel at least 10% across the State
  • Current unrestricted license or certification in applicable field preferred (i.e. RN or CPHQ)
17

Senior Clinical Project Administrator Resume Examples & Samples

  • Thorough knowledge of the contents of investigator documents and the applicable regulations and Covance Standard Operating Procedures for their use
  • Strong, proven administrative experience in a corporate environment or Clinical Project Administrator experience
  • Demonstrated attitude for training
18

Clinical Trial Administrator Resume Examples & Samples

  • Participate in the completion of the RFPs in collaboration with the Lead CPM/CPMs
  • Manages study related payment procedures with the dedicated Resource Administrator
  • Provides input for budget development and checks monthly costs invoiced to Company based on planned study activities vs actual
  • Prepares / assembles study documentation (submission package to Regulatory Authorities and Ethics Committees, study documents prepared through DOC compliance, reviews English texts and translations, CSR, publications)
  • Handles and maintains paper TMF and electronic internal repository according to ICH/GCP guidelines and US standards. Responsible for paper TMF reconciliation after study completion
  • Interacts with external providers during study conduct (CROs, monitors and, occasionally, with investigators and Hospital personnel)
  • Collaborates with Lead CPM/CPM, , CTS Unit and QA in order to manage activities related to Clinical Trial Supplies: if required prepares and assembles labels, sends labels to CRO asking for certified translations in the applicable languages, prepares the CTS Request Form for validation by the Lead CPM/CPM, Validates the CTS reconciliation at the end of the study for the Lead CPM/ CPM to authorize the destruction
  • Organizes and/or participates Kick Off Meetings, Study Design Meetings, and phone-conferences with the CROs for the continuous update on clinical studies. May participate if required to the Investigator’s Meetings
  • Assists the eCTD team in the formatting of all documentation related to a clinical study, aimed at obtaining an electronic copy of the registration dossier
  • When required, capable of coordinating study feasibility in direct contact with study sites
  • 2-4 years previous experience in Pharma or CRO environment in a similar capacity
  • Knowledge of ICH / GCP Guidelines, FDA Guidelines, and company SOPs
19

Clinical Administrator Resume Examples & Samples

  • Proficient user of Microsoft Outlook
  • Ability to discreetly handle confidential information as required
  • Able to plan and organize own workload by establishing objectives, assignments and target dates
  • Previous experience within a PA/secretarial role
  • Good knowledge of R&D
  • Providing a comprehensive proactive admin service
  • Routinely handling all admin/secretarial duties, including setting up meetings, scheduling appointments, maintaining calendar and proactive email management for the department Director
  • Arranging meetings, events and conferencing (telephone and video) involving groups of people in different locations and organizations
  • Arranging international and domestic travel arrangements (prepare itineraries, transportation arrangements)
  • Communication with other departments, outside companies, consultants, vendors and internal GSK senior managers
  • Prioritizing work to meet department needs, exercising initiatives and judgement in making decisions
20

Clinical Project Administrator Resume Examples & Samples

  • Regulatory & Site Start-Up responsibilities: Preparation of submission package for IRB/ERC and support regulatory agencies submissions
  • Budgeting: Collaborate with finance/budgeting representatives for payments (investigators, vendors, grants)
  • Meeting Planning: 1) Organize meetings (create & track study memos/letters), 2) Meeting planning for local investigator meetings (invitations, prepare materials, select venue, support vendor where applicable)
  • Document management: 1) Prepare documents and correspondence, 2) Collate, distribute, and archive clinical documents (i.e. TMF), 3) Updating trial manuals/documents (e.g., patient diaries, instructions)
  • Trial and site administration: 1) Tracking (e.g. essential documents) and reporting, 2) Ensure collation and distribution of study tools and documents, 3) Update clinical trial databases (CTMS)
  • University degree with life science preferred
  • Candidate with 1 year or more relevant RA/IRB submission experience in pharma or CRO
  • Thorough knowledge of ICH GCP and regulatory
  • Fluent in local language and English
  • 1 or more years CR experience in pharma or CRO
  • Excellent monitoring skill, site management skill, communication skills
  • Ability to work independently, good planning and organization skill, computer skills
21

Clinical Project Administrator Resume Examples & Samples

  • Act as contact for project team and study sites
  • Perform CRF review, query generation and resolution against established data review guidelines, under direct supervision on Covance or client data management systems, as assigned by management
  • Assist with generation and reconciliation of queries to investigative sites/clients to resolve problem data
  • Assist with the management of study supplies and organize shipments
  • Create, update, track, and maintain study-specific trial management files, tools, and systems
  • Assist the local project team members with other administrative activities as required (e.g. payments to investigators, correspondence with clients, preparation of status reports, and organization of investigators’ meetings)
  • Co-ordinate meetings with clients, investigators, and project team, including taking minutes
  • Ensure compliance with Covance SOPs, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work
  • Provide input in writing Monitoring Conventions as assigned
  • Assist in submissions and notifications to Ethics Committees and Regulatory Authorities
22

Clinical Trials Master File Administrator Resume Examples & Samples

  • Act as an SME supporting the management and oversight of TMF activities for paper, electronic and customer TMF systems to ensure delivery of a high quality TMF
  • Follow processes for set up, maintenance, and support for assigned TMF projects as required
  • Monitor, identify and record quality problems, suggest, initiate, recommend or provide solutions as appropriate
  • Facilitate collecting, processing and disposition of various project-related records for paper & electronic documents to sponsor
  • Follow applicable SOP’s to ensure completeness & accuracy of the TMF
  • Follow records management tasks, policies, and procedures
  • Collaborates on TMF Quality for assigned sponsor trials
  • In Depth Knowledge of and skill in applying applicable clinical research regulatory requirements/global international records standards to the area of expertise; e.g. Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines; DIA Reference Model
  • Knowledge of technology applications and reporting mechanisms relevant to records management/TMF environments, including electronic signatures and records
  • Strong software and computer skills, including MS Office applications
  • An ability to demonstrate a critical eye & strong attention to detail
  • Self-motivation and ability to work independently under limited direction or in a group setting as required
23

Clinical Trial Master File Administrator Resume Examples & Samples

  • Conduct review of documents with compliance to Quintiles or customer file plans and SOPs
  • Serve as a TMF contact for documentation to the project team, and cross functional departments to ensure high quality TMF deliverables are met on time
  • Manage documentation associated with assigned clinical trials
  • Provide support & involvement with internal quality or audit process’s as relevant
  • Bachelors degree in a Scientific discipline, combined with an interest in developing a career with Clinical Research
  • Excellent oral/written communication, and interpersonal skills
24

Clinical Trials Administrator Resume Examples & Samples

  • Coordinates the data management activities of the Phase I Clinical Trials Program Liaison between study team, CRO & Sponsor (e.g. monitor visits, data discrepancies, etc.) Maintains pertinent records and documentation, locate ICD-9 codes for adverse events and adhere to CTCAE guidelines, follow assigned research participants from recruitment through treatment, discharge and follow-up, responsible for collecting, recording, and preparing data for industry sponsored trials
  • Oversees the delivery of high quality data from case analysis, data abstraction, and database management from multiple clinical databases. Reviews clinical and external data for subjects enrolled in clinical research protocols based on protocol specifications SAE/AE/CRF data processing. Reconciliation of SAE/AE/concomitant medications according to established data management guidelines set by the Sponsor Report study enrollment (active, follow-up, screen failures), Oversee the scheduling and coordination of all monitoring visits. Provide study related information to the monitor and serve as the primary resource during monitoring visits, Ensure data has been entered and monitored for close-out visits. Set-up close-out visit for Pharmacy and PI
  • Attend weekly departmental meetings; participate in regulatory/compliance and educational clinical training as required by institutional policy and department Serve as back-up for CRCs during internal meetings by providing patient updates
25

Clinical Project Administrator Resume Examples & Samples

  • Provide clinical support for projects according to Standard Operating Procedures, ICH Guidelines and GCP
  • Manage and control TMF upload by the CRO
  • Ensure compliance with S.O.P.s, FDA, ICH, and GCP regulations for clinical conduct in all aspects of daily work
  • Manage invoicing part
  • Previous experience in a corporate environment; experience within clinical research (3 years)
  • Computer literacy (word processing and spreadsheet software)
  • Aptitude for handling and reviewing numerical data
  • Fluency in French and English language
26

Clinical Project Administrator Resume Examples & Samples

  • Provide clerical support to project team (e.g., word processing, proofreading and editing correspondence, large and small documents, mailings, shipment of study files, fax and photocopy documents, assemble study documents, and arrange meetings, etc.)
  • Prepare monitoring visit documentation for Clinical Research Assistants and above, as requested by supervisor
  • Perform other administrative duties as assigned by management
  • Clinical experience, preferably in the similar position
27

Clinical Trials Project Administrator Resume Examples & Samples

  • Coordinates and implements clinical trials projects. Manages daily activities of established clinical trials
  • Plan, initiate and manage clinical trials projects. Maintains clear and frequent communication with the client and reviews daily activities of ongoing clinical trials with the program manager
  • Provides daily management of the project through internal and external co-ordination and follow up during the project life cycle
  • Interacts with project team members to resolve and troubleshoot problems related to specimens, result reporting and site compliance
28

Clinical Project Administrator Resume Examples & Samples

  • Prepare study related documents and other materials for delivery to archives; investigator budget payment and tracking systems; generate tracking report as assigned
  • Prepare monitor visit document for CRA
  • Data entry and maintenance of selected study tracking data
  • Vendor coordination and client meeting preparation work
  • 1 year experience of relevant clinical research field in college, or industry
29

Clinical Administrator Resume Examples & Samples

  • Extensive knowledge of the functions of all aspects of Diagnostic Radiology and Nuclear Medicine and the ability to bring about strategic change, internally and externally, to meet organizational goals
  • Leadership, management, administrative and educational background with radiologic technology skills and experience to manage a large Radiology Department affiliated with a University Medical Center and to serve as the administrative and supervisory liaison between the services of the Radiology Department and other services within the Medical Center
  • Extensive knowledge of financial planning and budget analysis demonstrated through education and progressively responsible management experience in a healthcare environment
  • Ability to make and implement major managerial recommendations for the radiology program, such as organizational improvements including changes in structure and delegation; realistic cost/benefit ratios; and policy and procedure changes to improve service to patients
  • Ability to perform the full range of supervisory duties, including responsibility for assignment of work performed; performance evaluation; recommendations for appointment, awards, advancement, and when appropriate, disciplinary actions; and identification of continuing education and training needs
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Clinical Project Administrator Resume Examples & Samples

  • The position will oversee day-to-day operations of various projects and grants, interface with interprofessional healthcare teams, state agency funders, and ensure compliance and reporting requirements per project deliverables
  • Serves as liaison and collaborate with PGHC interprofessional clinic, telehealth center and Wellmobile healthcare providers in developing operations processes, data and financial tracking systems for management of interprofessional clinic, telehealth services and Wellmobile resources
  • Identify and assist in the development of future business process changes. Apply knowledge of financial management systems application to organization-specific needs and processes; assist in modifying functional designs to enhance functionality of reporting and tracking
  • Research regulations and law related to interprofessional clinic and telehealth services. Apply state and federal regulations and policies, ethical standards, relevant University policies, and public responsibilities when developing business processes/standard operating processes for clinic and telehealth operations
  • Oversees record keeping, data collection, management, and analysis. Prepares and presents program reports
  • Ensures consistency and quality of financial and clinical data with responsibility for training, problem resolution and end user-supports
  • Assist in writing grant applications and contract proposals including large scale program project grant proposals. Ensures necessary reviews of budget, salaries, and terms are met within deadlines
  • Skill in strategic and analytic thought with an ability to solve problems and make decisions
  • Skill in establishing and maintaining effective working relationships. Excellent oral/written communication and interpersonal skills
  • Ability to prioritize, plan, and execute multiple complicated and continuing contract and grant assignments in a timely manner
  • Working knowledge of word processing and spreadsheet computer software packages and financial systems
  • Knowledge of financial systems applications and accepted business process and practices
  • Knowledge and management of project management tools and resources
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Clinical Administrator Resume Examples & Samples

  • Recruits, interviews, hires, supervises, evaluates and disciplines nursing personnel, residents and fellows, and support staff; oversees, manages and authorizes personnel transactions. Participates in the recruiting, interviewing and hiring of physicians
  • Develops and manages the annual budget; analyzes, monitors and directs the reconciliation of the budget; authorizes and directs the payment of clinical expenditures
  • Participates in planning for future needs of the unit/department including space planning and long and short term planning in order to meet health care objectives and clinic goals
  • Assesses health care needs, performs diagnostic procedures andevaluates results in order to provide direct nursing care to patients
  • Participates in teaching curriculum to residents, medical students and nursing students; participates in research programs and in coordinating and conducting research projects
  • Investigates, implements, and revises health care objectives, standards, and practices in order to maintain quality care of patients; develops new systems accordingly
  • Prepares financial and productivity reports; participates in the establishment and annual review of the fee schedule
  • Formulates, implements, and administers operational, administrative and nursing and medical assistant policies and procedures for the unit/department
  • Assists in the administration in the financial aspects of contract negotiations and manages contracts
  • Develops and implements marketing and public relations activities
  • Participates in strategic business planning activities
  • Represents the unit/department to other University departments and government agencies to make preliminary commitments on administrative policies, procedures, budgetary and account concerns
  • Coordinates maintenance and renovations of physical facilities and serves as Unit safety officer that includes the evaluation and recommendation of safety procedures and education of staff
  • Provides counseling or instruction to patients regarding their symptoms, diagnosis and recovery; refers as appropriate
  • Monitors and directs the collection and billing process, including setting annual targets, auditing payments; resolving billing disputes with patients and respective insurance and department; interpreting and explaining medical billings
  • Serves as a member of and liaison to educational, community and professional organizations
  • Attends conferences, staff development programs and workshops
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Associate Clinical Administrator Resume Examples & Samples

  • Partner with Chief Administrator and provide strategic planning and business development recommendations for the divisions and other
  • Responsible for the division’s fiscal operations
  • Monitor and approve expense allocations for Division
  • Ensure compliance with MCP and MCW policies and procedures
  • Responsible for execution of strategic planning within the division
  • Operationalize divisional clinical program development
  • Recruit, hire, orient, train, discipline and conduct annual reviews for direct reports
  • Facilitate workforce planning, supervise appropriate staff and orient new employees in clinical and research areas. Staff includes administrative, clinical (APPs) and basic science and clinical research staff
  • Maintain compliance with employee procedures and guidelines
  • Manage visa process for employees and serve as the main contact for all Divisional Human Resources matters
  • Supervise, mentor and coach direct reports and allocate tasks
  • Annually recommends compensation increases for direct reports
  • Ensure that administrative policies are in compliance with MCW policies
  • Oversee the operational activities of the division ensuring efficiency and compliance with department and College policies and procedures
  • Responsible for the development and implementation of tactical plans to achieve goals in collaboration with the Department and Froedtert Hospital
  • Coordinate the organizational change process for practice improvement
  • Facilitate staff development
  • Facilitate business operational planning
  • Develop and implement process improvement programs for clinical and research operations
  • Develop and implement clinical programs including off-site locations
  • Interface with hospital leadership and clinic personnel to create and implement processes for patient care delivery
  • Assist the Division and Department Leadership in development of the strategic plan for the divisions
  • Monitor and evaluate effectiveness of strategic, business, and marketing plans
  • Responsible for coordination of departmental projects, including but not limited to financial analyses, operational process improvement using principles of LEAN and other advanced management tools
  • Responsible for interim Division Administration as needed
  • Manage and/or collaborate with clinic managers so as to facilitate efficient outpatient services
  • Assist in the development and execution of efficient departmental systems
  • Participation in strategic planning
  • Acting as a department liaison
  • Communicate college and department policies and serve as a resource on these policies and procedures to staff and faculty
  • Administer grants and assist with developing grant proposals
  • Oversee database management and maintenance
  • Lead and manage the organizational change process for division/practice improvement
  • Coordinate, plan and implement office activities and procedures
  • Develop and implement the recruitment, interview, orientation, graduation and other medical education/residency program activities
  • Coordinate clinical and basic science research including IRB submission, etc
  • Professional Responsibility
  • Advance professional knowledge and leadership skills
  • Engage in professional networking
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Clinical Scanning Administrator Resume Examples & Samples

  • High School Diploma/GED, Associate Degree in Business Management or related field preferred
  • 5-8 years experience in a business or medical office environment
  • Minimal travel, <5%
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Clinical Project Administrator Resume Examples & Samples

  • University or college degree (life science preferred)
  • Experience in similar tasks in Clinical Trials
  • Fluency in local and English language
  • Aptitude for handling and proofreading numerical data
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Senior Clinical Project Administrator Resume Examples & Samples

  • Provide clerical support to the project team
  • Work with contractors for invoices, follow-up of finances, request for buying
  • Administrative Assistant for Research department (organization, welcome new starters)
  • Provide telephone coverage and related support duties
  • Update database and systems
  • Participate to audit/inspection preparation if applicable
  • Working with Records specialists for optimization of e-TMF
  • Participate and contribute to projects and department meetings
  • Diploma Secondary Education or equivalent
  • Administrative experience in a corporate environment or Clinical Project Administrator experience
  • Ability to operate standard office equipment