Sutter Health Regulatory Analyst in San Francisco, California
PRIMARY PURPOSE: Under the supervision of the Clinical Research Manager or Director and in collaboration with the clinical research staff, this position carries out the human subject's regulatory requirements for designated clinical trials at CPMC Research Institute.
Prepares protocols for submission to the Institutional Review Board (IRB) and any other appropriate 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 IRB completing all appropriate modified documents.
Tracks and submits annual IRB progress reports for individual clinical studies on a timely basis.
Maintains regulatory binders for specific clinical trials in compliance with institutional Standard Operating Procedures and other Guidelines and Procedures.
Acts as the primary regulatory contact between the study site, the sponsor organization and the IRB.
Routinely updates principal investigators and staff regarding the regulatory status of individual protocols.
Acts as a liaison between the IRB staff contributing to an efficient regulatory process.
High School Diploma or equivalent education/experience required. B.S. or B.A. preferred
Knowledge of the design and conduct of clinical trials; medical terminology; and regulatory requirements.
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 clinical research team.
Organization: California Pacific Medical Center
Employee Status: Regular
Employee Referral Bonus: No
Position Status: Exempt
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.