Sutter Health Regulatory Analyst-Research Institute in San Francisco, California

Description

PRIMARY PURPOSE: Under the supervision of the Administrator of Comparative Medicine and in collaboration with the Basic Science research staff, this position carries out the regulatory requirements for comparative medicine research protocols at CPMC Research Institute.

Productivity /Efficiency

  • Prepares protocols for submission to the Institutional Animal Care and Use Committee (IACUC), and any other appropriate review committee (e.g. Institutional Biosafety or Conflict of Interest), in accordance with committee standards, applicable regulations, and individual sponsor requirements.

  • Reviews and submits protocol modifications to the IACUC, completing all appropriate modified documents.

  • Tracks and submits annual IACUC progress reports for individual research studies on a timely basis.

  • Maintains regulatory binders for specific segments of the CPMCRI Program of Comparative Medicine in compliance with institutional Standard Operating Procedures and other Guidelines and Procedures.

Communication

  • Acts as the primary regulatory contact between the research scientists submitting protocols, and the IACUC.

Routinely updates principal investigators and staff regarding the regulatory status of individual protocols.

  • Acts as a liaison between the ACF staff and the IACUC, to assist in the coordination of research studies, contributing to an efficient regulatory process.

Quality

  • Promptly and accurately assists in the preparation of submissions to the IACUC or other required review committees and processes requested changes for final project approval.

  • Develops and implements procedures for the efficient management of regulatory requirements.

Technical Skills

  • Requires knowledge of institutional, federal, state, and local research regulations and guidelines; medical terminology.

Service Standards:

  • Consistently exhibits Service Standard behaviors set forth in the attached Service Performance Standards (see attached listing).

CPMC Citizenship.

  • Adheres to all Medical Center policies and procedures (i.e. Administrative and Human Resources), practices safe work habits, and engages in good business standards and practices.

Qualifications

Education: High School Diploma or equivalent education/experience required. B.S. or B.A. preferred

Knowledge: Knowledge of the design and conduct of research protocols; medical terminology; and regulatory requirements.

Skills: Requires a highly organized individual who can handle multiple complex tasks effectively and efficiently and work with minimal supervision. Demonstrated proficiency in written and oral communication skills. Ability to participate effectively as a member of a scientific research team.

Primary Location: California, San Francisco, San Francisco

Organization: California Pacific Medical Center

Employee Status: Regular

Employee Referral Bonus: No

Benefits: Yes

Position Status: Exempt

Union: No

Job Shift: Day

Shift Hours: 8 Hour Shift

Days of the Week Scheduled: Monday-Friday

Weekend Requirements: None

Schedule: Full Time

Hrs Per 2wk Pay Period: 80

All qualified applicants will receive consideration for employment without regard to race, color, creed, religion, marital status, sexual orientation, registered domestic partner status, sex, gender, gender identity or expression, ancestry, national origin (including possession of a driver's license issued to individuals who did not present proof of authorized presence in the U.S.), age, medical condition, physical or mental disability, military or protected veteran status, political affiliation, pregnancy or perceived pregnancy, childbirth, breastfeeding or related medical condition, genetic information or any other characteristic made unlawful by local, state, or federal law, ordinance or regulation. External hires must pass a background check/drug screening. Qualified applicants with arrest and/or conviction records will be considered for employment in a manner consistent with Federal, state, and local laws, including but not limited to the San Francisco Fair Chance Ordinance.