The Regulatory Affairs Associate assists the HVTN clinical trial sites and the coordinating center with meeting clinical trials regulatory requirements as outlined by the FDA, the ICH, and NIH in our cooperative agreement and other documents. This position focuses on providing human subjects protection expertise and expertise in Institutional Review Board (IRB) or Ethics Committee review to clinical trial sites. This position works with minimal direction from the Regulatory Affairs Director to complete regulatory projects for the unit and network and provides guidance to clinical trial sites on regulatory issues.
The incumbent acts as liaison between the HVTN regulatory staff, the NIH regulatory contractors, and the clinical trial sites. The incumbent works independently with the FHCRC Institutional Review Office (IRO) and the Office of General Counsel in consultation on regulatory compliance issues. The incumbent provides human subjects protection knowledge and expertise to help facilitate ethical review of clinical trial sites. The incumbent works independently in performing job assignments and uses good judgment in developing and documenting procedures, preparing reports and distributing communications. The incumbent may coordinate special regulatory projects. S/he reports to the Regulatory Affairs Director.
1. Assist clinical trial sites in obtaining necessary materials to satisfy Food and Drug Association (FDA), International Conference on Harmonization (ICH), and HVTN regulatory requirements. The specific tasks include:
- Perform regulatory review of site-specific informed consent forms (ICFs), as needed. Maintain documentation of the review. Communicate any changes needed to the clinical trial sites.
- Assist sites with preparing submissions to their regulatory bodies, including, but not limited to providing required supplemental documentation and responding to queries. - Compile documentation of site's annual IRB reviews, IBC reviews, as required, and OHRP federalwide assurances. Remind sites of upcoming reviews to prevent lapses in approval.
- Ensure distribution and translation of regulatory documents to clinical trial sites, as needed.
- Track the required regulatory documents needed for protocol activation from participating sites. Perform review of documents for completeness and accuracy. - Distribute protocol activation communications allowing enrollment to start at each site once regulatory documents are in place.
- Provide consultation to site staff on regulatory compliance. - Review site SOPs for adherence to research regulations and network policies. - Conduct regulatory trainings either on site, at network meetings, or via conference call.
2. Manage the Lead IRB review of HVTN research.
- Serve as the liaison between the "Lead IRB" sites on a protocol, the FHCRC Lead IRB for that protocol, and the consulting reviewer from the institution authorizing review, as needed.
- Develop policies and procedures for a smooth operation of "Lead IRB" review with FHCRC serving as the IRB-of-record;
- Create standard operating procedures (SOPs) or work practice guidelines (WPGs)/checklists to assure proper implementation of the procedures developed. - Evaluate the impact of the Lead IRB and document improvements that have been made and those that are needed.
3. Assist the HVTN regulatory staff in meeting regulatory requirements. The specific tasks include:
- Coordinate the coordinating center's annual continuing review submission to the FHCRC IRO.
- Develop HVTN protocol sample ICFs and represent regulatory issues on protocol teams throughout the life of a study.
- Manage Financial Disclosure/Conflict of Interest (FD/COI) process according to the cross-network SOP, including, but not limited to, managing the FD/COI database, annual solicitation, and regular committee meetings/calls.
- Help develop systems for regulatory compliance at the HVTN coordinating center. - Document operating procedures using SOPs, WPGs, and checklists so others may fill in if needed.
- Maintain the regulatory files. Conduct routine audits of files, write compliance report, and correct deficiencies.
4. Adhere to SOPs of the HVTN.
5. Oversee special regulatory projects with minimal oversight.
For minimum qualifications and to apply, please visit: https://careers-fhcrc.icims.com/jobs/5646/regulatory-affairs-assoc/job?h... />
We are a VEVRRA Federal Contractor.
If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2246131-2647-9321