Regulatory Affairs Associate

Heluna Health; San Francisco (CA); On-site; USD 75,000 - 110,000; Full time

Job summary

Heluna Health in San Francisco seeks a Regulatory Affairs Associate to support Bridge HIV, a grant-funded research unit affiliated with DPH and UCSF. You will handle regulatory submissions, SOP development, and document control under the Medical Director.

This onsite, full-time role requires collaboration with study sites, regulatory bodies, and staff to ensure strict adherence to guidelines, HIPAA, and ethical standards. Jointly funded, grant-based employment.

Qualifications

• Degree in biological or related field with experience in coordinating clinical trials.
• Experience with IRB applications and regulatory submissions.
• Ability to develop and implement QA measures for research studies.

Responsibilities

• Submit and track IRB applications for studies including renewals and deviations.
• Maintain study documentation, sponsor communications, and archiving records.
• Draft SOPs and ensure version control and dissemination of docs.
• Collaborate with study personnel on protocols, training, and implementation.
• Lead regulatory group meetings and address compliance issues.

Skills

IRB coordination

Quality assurance

Regulatory submissions

Documentation management

Project collaboration

Education

Bachelor in biological or related field

Tools

Word

Excel

PowerPoint

Access

Trello

Job description

25 Van Ness Avenue, Suite 100, San Francisco, CA 94102, USA

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. The position reports to the Medical Director and involves working with a dynamic team conducting biomedical intervention studies, including HIV vaccines, pre‑exposure prophylaxis, and STI prevention.

This is a temporary, grant‑funded, full‑time, benefitted position. Employment is provided by Heluna Health. The role is onsite Monday‑Friday.

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) and manage on‑site storage, archiving, and destruction.
• Draft Standard Operating Procedures (SOPs) 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.
• Plan and implement the Quality Management System, including 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 that 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, including 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.

Qualifications

• Education/Experience
  • 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 a 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.
• Other Skills, Knowledge, and Abilities
  • Detail and deadline oriented; ability to manage multiple assignments under tight deadlines.
  • Ability to work independently, 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.
  • Proficiency with 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, 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, and transgender communities.

Physical Demands

• Stand, Walk, Sit, See, Handle/Fingering, Reach Outward, Reach Above Shoulder, Climb, Crawl, Kneel, Bend: Occasionally (0‑2 hrs/day).
• Lift/Carry, Push/Pull: Occasionally – up to 50 lbs.
• Frequency categories:
  • Not required for essential functions
  • Occasionally (0‑2 hrs/day)
  • Frequently (2‑5 hrs/day)
  • Constantly (5+ hrs/day)

EEOC Statement

Heluna Health is an affirmative action, equal opportunity employer that encourages minorities, women, veterans, and disabled individuals to apply. All qualified applicants will be considered for this position in accordance with the San Francisco Fair Chance Ordinance. It is the policy of Heluna Health to provide equal employment opportunities to all employees and applicants, without regard to age (40 and over), national origin or ancestry, race, color, religion, sex, gender, sexual orientation, pregnancy or perceived pregnancy, reproductive health decision making, physical or mental disability, medical condition (including cancer or a record or history of cancer), AIDS or HIV, genetic information or characteristics, veteran status or military service.