Regulatory Affairs Associate

Public Health Foundation Enterprises

Regulatory Affairs Associate (Healthcare)

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

A variety of soft skills and experience may be required for the following role Please ensure you check the overview below carefully.

• 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

Other Skills, Knowledge, and Abilities

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

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.

Equal Opportunity Employer / Protected Veterans / Individuals with Disabilities.

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Salary : $36