Regulatory Affairs Associate

Heluna Health invites applications for one 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. Bridge HIV has been searching for new and innovative ways to fight HIV/AIDS since the onset of the epidemic in the early 1980s. 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. In response to the COVID-19 pandemic, Bridge HIV has also been conducting COVID-19 vaccine and epidemiology studies. 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 team conducting studies to prevent HIV.

If hired for this position, you will be required to provide proof that you are fully vaccinated for COVID-19 prior to your start date, or have a valid religious or medical reason qualifying you for an exemption (that may or may not require accommodation).

This is a temporary, grant-funded, full time, benefitted position. Employment is provided by Heluna Health.

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

Pay rate: $36.33

ESSENTIAL FUNCTIONS
• Submit and track IRB/RE applications for initial review, modification and renewal of study protocols
• Maintain all study administration documentation (IRB communications, sponsor communications, licensure, study initiation agreements,) on-site storage, archiving and destruction
• 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.
• Ensure staff compliance with mandatory institutional and regulatory training requirements - Includes HSP, GCP, GLP and SOPs

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, and Access
• 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 Up to 50 lbs Occasionally
Push/Pull up to 10 lbs Occasionally
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 without regard to race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, genetic information or any other protected characteristic under applicable law.

Salary : $36