Regulatory Affairs Associate

Heluna Health invites applications for the full-time position of Regulatory Affairs Associate.

Bridge HIV is a grant-funded research unit affiliated with the San Francisco Department of Public Health and the University of California San Francisco.

Under the direction of Susan Buchbinder, MD, Bridge HIV has been conducting HIV and STI preventive vaccine studies, HIV pre-exposure prophylaxis (PrEP) studies (including oral and injectable medications), and other studies of biomedical HIV prevention strategies since the early days of the epidemic.

The Bridge HIV Investigators are global leaders in HIV vaccine and prevention science, epidemiology of HIV infection, HIV medication adherence, combination HIV prevention strategies, and HIV research training methods.

For more information, please see www.bridgehiv.org.

Under the direct supervision of the Medical Director, the Regulatory Affairs Associate will be part of a dynamic team conducting biomedical intervention studies (HIV vaccines, pre-exposure prophylaxis, and STI prevention).

This is a temporary, grant-funded, full-time, benefitted position.

Employment is provided by Heluna Health.

This position is onsite Monday-Friday.

Interested individuals should submit a cover letter and resume for consideration.

ESSENTIAL FUNCTIONS
• Submit and track Institutional Review Board (IRB) applications for initial review, modification, renewal, and protocol deviations for study protocols
• Maintain all study administration documentation (IRB communications, sponsor communications, licensure, study initiation agreements,) on-site storage, archiving and destruction
• Draft Standard Operating Procedures (SOP) and ensure document version control and dissemination for all SOPs, consents, protocols and amendments
• Communicate and collaborate with key study personnel on upcoming projects, protocols, and operational implementation
• Provide guidance to site staff on current research guidelines, regulatory and institutional policies
• Serve as liaison among study sites, DPH, and other regulatory entities.
• Quality Management System planning and implementation - includes conducting quarterly audits, preparing quarterly and annual reports and creating corrective and preventative action plans
• Lead and manage the Regulatory Working Group, a cross-team collaborative group which meets monthly to revise and develop site SOPs, address organization-wide regulatory issues, and establish standard practices for reporting and documentation.
• Track and ensure staff compliance with mandatory institutional and regulatory training requirements - Includes HSP, GCP, GLP and SOPs.
• Draft, review, submit, and track Corrective and Preventative Action (CAPAs) plans for study protocol deviations in collaboration with study coordinators.

JOB QUALIFICATIONS

Education/Experience
• Demonstrates strong commitment to anti-racism and health equity
• Degree in biological or social sciences, survey research, public he...