Regulatory Affairs Associate at Heluna Health

San Francisco, California, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Oct, 26

Salary

0.0

Posted On

15 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

IRB Application Management, Clinical Trial Monitoring, Quality Management Systems, SOP Development, Regulatory Compliance, CAPA Planning, Human Subjects Protection, HIPAA Compliance, Project Management, Technical Writing, Audit Conducting, Interpersonal Communication

Industry

Non-profit Organizations

Description

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 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 Other Skills, Knowledge, and Abilities • 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 PHYSICAL DEMANDS • Stand: Frequently • Walk: Frequently • Sit: Frequently • Handling / Fingering: Occasionally • Reach Outward: Occasionally • Reach Above Shoulder: Occasionally • Climb, Crawl, Kneel, Bend: Occasionally • Lift / Carry: Occasionally - Up to 50 lbs • Push/Pull: Occasionally - Up to 50 lbs • See: Constantly • Taste/ Smell: Not Applicable Not Applicable Not required for essential functions Occasionally (0 - 2 hrs/day) Frequently (2 - 5 hrs/day) Constantly (5+ hrs/day) WORK ENVIRONMENT General Office Setting, Indoors Temperature Controlled Heluna Health is an Affirmative Action, Equal Opportunity Employer that encourages minorities, women, veterans, and disabled to apply. All qualified applicants will be considered for this position in accordance with the San Francisco Fair Chance Ordinance EEOC STATEMENT 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.

Responsibilities

The Regulatory Affairs Associate manages IRB applications, maintains study documentation, and ensures compliance with research guidelines and institutional policies. They also lead the Regulatory Working Group and implement Quality Management Systems, including audits and CAPA plans.