Research Regulatory Specialist

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Examines, evaluates, and investigates conformity with the regulatory and billing aspects of industry and government sponsored clinical trials and investigator-initiated clinical research. This includes securing Institutional Review Board (IRB) approval and maintaining all records pertaining to IRB approval and oversight. Performs various duties, such as research, analysis and auditing in support of projects to assure compliance across all aspects of the research studies.

MINIMUM QUALIFICATIONS:

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1. Master's degree OR;

Bachelor’s degree AND Three years of experience in regulatory and research patient billing aspects of industry and government sponsored clinical trials including IRB application submissions OR;

Associate’s degree AND Five years of experience in regulatory and research patient billing aspects of industry and government sponsored clinical trials including IRB application submissions OR;

High School Diploma or Equivalent AND Seven years of experience in regulatory and research patient billing aspects of industry and government sponsored clinical trials including IRB application submissions.

PREFERRED QUALIFICATIONS:

EDUCATION, CERTIFICATION, AND/OR LICENSURE:

1. Obtain certification as a Research Professional through the Society of Clinical Research Associates (SoCRA) OR the Association of Clinical Research Professionals (ACRP) within two years of hire date preferred.

CORE DUTIES AND RESPONSIBILITIES: The statements described here are intended to describe the general nature of work being performed by people assigned to this position.  They are not intended to be constructed as an all-inclusive list of all responsibilities and duties.  Other duties may be assigned.

1. Plans and writes materials required for IRB submissions.

2. Reviews submission-related documents from clinical research protocols to ensure consistency with institutional compliance guidelines.

3. Develops and prepares informed consent documents according to institutional guidelines.

4. Submits IRB applications to appropriate electronic systems.

5. Manages all aspects of Centers for Medicare & Medicaid Services (CMS) and private insurance submissions for all protocols as required per study.

5. Submits study protocol amendments to the IRB.

6. Assists with the submission of IND safety reports and adverse event reports to the IRB.

7. Manages all aspects of IRB submissions and communicates with IRB administration regarding new submissions and approved protocols.

8. Monitors, evaluates and improves regulatory and research patient billing submission tracking/control systems.

9. Works closely with the Patient Billing Department and acts as a liaison to ensure patient bills are allocated properly.

10. Works closely with the clinical research specialist in ensuring compliance with study schedule of events and follow-up visits.

11. Assists with scheduling patient follow-up appointments to meet study visit windows, tracking visits, and reporting any deviations to appropriate entities.

12. Submits appropriate documents to close or suspend study protocols.

13. Assists in networking opportunities, and continuing education.

14. Maintains knowledge of professional principles, legal and/or reporting requirements affecting area of responsibility, and adheres to industry and government standards.

15. Assists the clinical research specialist for professional development and to determine course of customer service.

16. Talks with investigators, coordinators, and sponsors by telephone or in-person.

17. Responds to questions regarding regulatory issues.

18. Gathers anecdotal and raw data, assesses situation or program information, considers options, proposes resolutions, creates reports and translates data to graphical media or code.

19. Manages and performs the preparation of regulatory documentation for study monitoring visits.

20. Manages the completion of forms for IRB submissions, renewals, deviations, etc.

21. Assists with process and workflow of patient bills resulting from research procedures.

22. Trains users regarding electronic IRB applications.

23. Contacts investigators, coordinators, and sponsors to establish rapport, understanding and/or inform, as well as to facilitate use