Regulatory Compliance Coordinator
Jobot - White Plains, NY
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Expanding health system needs exceptional compliance coordinator!This Jobot Job is hosted by: Bill KowskeAre you a fit? Easy Apply now by clicking the ''Apply Now'' button and sending us your resume.Salary: $75,000 - $95,000 per yearA bit about us:Well established hospital with great leadership at the helm. Community and care for the patients are our top priorityWhy join us?We have 403B, Health insurance, tuition reimbursement, paid time off and employee perks!Earn that MBA you want and get a discount on your tuition with established educational partner.Job DetailsEssential Functions and Responsibilities Includes the Following:1. Responsible for all aspects of clinical research regulatory compliance, including document preparation, submission and management for clinical trials.2. Collaborates with principal investigator(s) to develop, draft, and compile research protocol documents and all materials required for regulatory submissions in compliance with Food and Drug Administration (FDA) and Institutional Review Board (IRB) policies.3. Obtains and maintains required regulatory documentation and study specific regulatory binders for all studies4. Assures all site documents, including SOPs and administrative files, are maintained in audit-ready condition.5. Remain informed of current federal, state, and local regulations regarding clinical research and communicate any changes to study team.6. Acts as a liaison between the Principal Investigators (PI) and internal and external parties necessary for protocol development and activation. 7. Prepares and processes applications for internal committee reviews and approval of new clinical research trials, protocol revisions, annual renewals, and final study reports.8. Develops the consent form, HIPAA authorization form, and other IRB-required forms specific to each protocol.9. Compiles research protocol documents and all materials required for regulatory submissions in compliance with institutional and federal policies.10. Manage new study initiation process and provide regulatory guidance/support throughout the duration of the project.11. Revise submissions in response to identified problems and resolve issues in a timely manner; inform clinical research team on revisions and remedies.12. Report pertinent safety data and deviation notifications (Unanticipated Problem report) to the IRB.13. Prepares and participates in Study Initiation Visits and Interim Monitoring Visits.14. Participate in required teleconferences, on-site meetings and off-site investigator meetings, as required.15. Understands and adheres to the HOSPITAL Performance Standards, Policies and Behaviors.16. Performs all other related duties as assignedEducation & Experience RequirementsExperience: Minimum of one (1) year of experience in the field of regulatory documentation management or clinical research required. Experience submitting IRB applications (new and amendments) preferred. Knowledge of clinical trial federal, state and local regulations preferred. Extensive knowledge of Microsoft Office (Word, Excel, and Adobe Acrobat) including Tracked Changes functionality required. Excellent interpersonal and communication skills required. Understands and adheres to the HOSPITAL Performance Standards, Policies and Behaviors Education: Bachelor''s degree required, in relevant field preferred. Research certification (e.g. RAPS, ACRP, SoCRA or equivalent) preferred.Core Competencies Prepares and submits all study document applications, amendments, continuing reviews, final review for Internal IRB, BRANY IRB, and CIRB review and approval. Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), etc. Prepares, maintains and organizes regulatory files for each assigned study in compliance with study sponsor requirements. Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion. Coordinates assigned study monitoring and auditing visits with study coordinator, investigator, industry sponsors, and internal/external auditors.Clinical Trial Management Track and manage assigned new protocol start-up packet; initiate, facilitate and monitor study start-up progress. Coordinate study agreements and budgets with Research Administration and the sponsor. Create and maintain tracking for all subsequent submissions to the SRC/IRB; protocol and consent amendments, all required safety reporting, all required deviations/violations, etc. Ensure various regulatory reporting requirements are met by the sponsor, FDA, IRB terested in hearing more? Easy Apply now by clicking the ''Apply Now'' button.
Created: 2021-11-29