Regulatory Affairs Associate

Heluna Health•San Francisco, CA

3d•Onsite

About The Position

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).

Requirements

Demonstrates strong commitment to anti-racism and health equity
Degree in biological or social sciences, survey research, public health, law, demography or a related field, or combination of relevant experience and education
Experience coordinating, monitoring, or auditing clinical trials
Experience with developing IRB and/or grant applications
Experience creating and implementing quality assurance measures related to clinical and behavioral research
Detail and deadline oriented. Ability to manage multiple assignments under tight deadlines. Proven skills in setting priorities coupled with demonstrated ability to be flexible
Ability to work independently, to use discretion and judgment to make informed decisions and carry out action plans
Ability to implement policies and procedures regarding confidentiality and security
Ability to develop training materials and conduct training workshops or in-services
Ability to use Word, Excel, PowerPoint, Access, and project management tools such as Trello
Ability to interpret and follow policy, and maintain a high level of confidentiality in performance of duties
Ability to gather, synthesize, and evaluate information and convey ideas clearly about policies, procedures, facts and records pertinent to routine and unusual situations
Strong interpersonal skills to establish and maintain cooperative and productive working relationships
Skill in reading and writing and editing standard English text, directives, business correspondence, presentations, and technical documents
Knowledge of federal and state laws, regulations, policies and procedures related to the protection of human subjects
Knowledge of confidentiality issues, state and federal laws, regulations, and policies governing health data privacy, including HIPAA
Knowledge of and sensitivity to diverse communities, particularly communities of color and gay/ lesbian/ bisexual/ transgender communities

Responsibilities

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.