Regulatory Associate, Philadelphia FIGHT

Posted by on December 19, 2011

Regulatory Associate, Philadelphia FIGHT

Posted on: December 5, 2011

Regulatory Associate

The Regulatory Associate is an exempt, full time position.

The Regulatory Associate (RA) is the liaison person to the FIGHT Institutional Review Board (IRB). The RA works closely with FIGHT’s Principal Investigators and Research Team throughout the duration of studies to ensure proper maintenance of all regulatory documents.

Qualifications: Bachelor’s Degree with related experience. Familiarity with CFR and FDA guidance documents and procedures is highly desirable. The position requires that the person have an extraordinary attention to detail.

Duties include but are not limited to:
• Coordinate the submission of a new protocol at FIGHT.
1. Collate and organize study materials that are sent by various sources (Sponsor, Study Coordinator, Principal Investigator).
2. Schedule and confirm the date and time of the IRB meeting each month.
3. Serve as facilitator and note-taker for each month’s meeting. Lead the IRB through each agenda item, and request an official vote or acknowledgement at the appropriate time. Make note of any questions or requests for follow-up information.
• Ongoing review of approved studies
1. Make copies and submit materials (new study materials, amended study materials, revised study materials, safety reports) to the Philadelphia FIGHT IRB.
2. Maintain copies of these submissions in the regulatory files, and provide copies to the respective Study Coordinator to be placed in the study binder.
3. Protocol progress reports which could be monthly, quarterly or semi-annually.
4. Submit all FIGHT SAE’s and sponsor safety reports.
5. Submit investigator brochures.
6. Submit all miscellaneous items, such as newsletters, informational pamphlets, drug warning letters.
• Prepare for and Follow-up after IRB meeting
1. Generate response correspondence for the IRB chair, as directed.
2. Forward copies of the IRB response letters to the appropriate parties (Study Coordinator, Principal Investigator, Sponsor), and maintain the original letters in the regulatory files.
3. Seek out any requested information for the board.
4. In conjunction with the Sponsor, make any IRB-requested changes to study materials. Resubmit these materials to the IRB for review, if necessary.
5. When applicable, submit study materials through expedited review.
6. Maintain the Philadelphia FIGHT IRB’s Federalwide Assuarance (FWA) standing and registration with the U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP).
7. Maintain and periodically review the Philadelphia FIGHT IRB’s Manual of Operations.
8. Meet with Sponsor study monitors on a regular basis to review the regulatory files and ensure their completeness and correctness.
• Maintain the following files:
1. Regulatory: Protocols, informed consents, investigator brochures, safety reports, FDA 1572 forms, submission letters, IRB responses, sponsor correspondence, advertisements, current and past Philadelphia FIGHT IRB rosters
2. Research team: Current and past CVs, current and past medical licenses, special certifications, NIH Protection of Human Research Participants certifications
3. Laboratory: Current and past CLIA, CAP, and PA Department of Health accreditations, current and past Lab Director CVs, laboratory normals
4. Meeting Minutes: Current and past meeting minutes, attendance sheets

The Regulatory Associate reports to the Executive Director.
The Regulatory Associate has no supervisory responsibilities.
The Regulatory Associate will be required to have Human Protection training and Good Clinical Practice training within 15 days of employment provided by Philadelphia FIGHT.

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