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Cleveland Clinic



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Health Care-Cleveland Clinic
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Job Title

Regulatory Coordinator Job


Reference Title
HR Use Only: Regulatory Coordinator
Hospital: Cleveland Clinic Florida
Department: RESEARCH
Job Code: 000730
Pay Grade: 15
Schedule: Full Time
Shift: Days
Hours: 8am - 5pm
Job Details:


Responsible for all regulatory aspects of clinical trial set up including completion of IRB application. Works with Principal Investigator and Research Coordinator to assure proper documentation in regulatory binders, conducts monitoring visits for clinical trials, is the main contact with the IRB Manager.


A. Education, Knowledge, Skills and Abilities

1. Bachelor’s Degree in Life Sciences required

2. Computer literacy (MS Word and Excel) desirable

3. Excellent command of written and verbal English language

4. Excellent interpersonal skills to coordinate with physicians, residents, other researchers, sponsors and other coordinators.

B. Required Length and Type of Experience

1. Minimum two (2) years working in the health care field or research industry

2. Familiar with research terminology and procedures

C. Required Licensure, Certification or Registry

1. Certification as Clinical Research Coordinator preferred


1. Communicates information concerning subject health and safety to RC and/or Principal Investigator in a timely and responsible manner.

2. Communicates concerns regarding ethical violations to the RC and/or Principal Investigator when appropriate.

3. Maintains Regulatory and IRB data integrity where applicable.

4. Assist in preparation for FDA and/or Internal Sponsor audits.

5. Communicates with RC and ensures usage of most recent IRB approved Informed Consent Forms are being used

6. Functions as a team player with the department and works effectively with other coordinators in the department to foster an efficient and productive environment for Clinical Research.

7. Maintains accurate and essential documents as required by the FDA, IRB, Sponsor and any other Regulatory agencies.

8. Reviews all regulatory study documents and develop a system to track study activity where appropriate.

9. Ensures all lab certification, licenses and normal ranges are maintained and current in regulatory documents/binder.

10. Ensures all CV’s and medical licenses are current and up to date in regulatory documents/binder.

11. Ensures all IRB correspondence and membership lists are maintained and current in regulatory documents/binder.

12. Oversees completeness or completes and/or corrects all FDA1572 forms submitted.

13. Ensures 1572 is filed appropriately in regulatory documents/binder.

14. Ensures all informed consent forms are up to date and filed correctly in regulatory documents binder.

15. Organizes and files all correspondence for each clinical trial.

16. Submits and organizes all IND reports received by the RC to the IRB as per the federal guidelines.

17. Submits and files all protocol deviations and/or violations presented by the RC in accordance with IRB and sponsor guidelines.

18. Submits adverse events presented by the RC in accordance with IRB guidelines.

19. Submits and files SAE’s presented by the RC to the IRB in accordance with the guidelines.

20. Prepares and assists monitors during visits with any issues related to regulatory documents.

21. Prepares and keeps the Study Signature Log/Assignment of Study Responsibilities Log current and filed as per federal regulations.

22. Files reports and summaries from sponsor, IRB, PI or Clinic administration as outlined in the study protocol or at the request of the parties listed.

23. Prepares protocol documents for IRB submission.

24. Prepares and submits IRB application.

25. Communicates to IRB regarding any deviations/violations from the protocol, as well as adverse events and serious adverse events.

26. Completes IRB renewal process as assigned and keeps abreast of due dates.

27. Keeps abreast of regulatory and compliance issues and communicates deviations to the IRB and Principal Investigator.

28. Submits and files study closures documents prepared by RC to the IRB.

29. Submit patient recruitment materials and study advertisements to IRB for approval in conjunction with the RC staff submitting to sponsor.

30. Submits informed consent forms to the IRB after RC and Sponsor revisions have been made at start of study.

31. Submits Informed Consent Forms for annual renewal to IRB on a timely basis and provides “clean copies” to appropriate personnel.

32. Completes annual IRB renewal applications accurately and submits in a timely manner.

33. Maintains complete and up-to-date documentation and file at all times.

34. Carries out work assignments with minimal supervision and exhibits good judgment.

35. Performs any other duties as assigned.

Category: Research

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