Job Abstract

• Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies / procedures to apply federal, state, and university regulations, policies, guidelines, and promote best practices.
• Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University.
• Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Attention to detail as errors or omissions may ultimately place research participant at undo risk and / or compromise the institution's assurance of regulatory compliance with the federal government.
• Clinicaltrial.gov registration and activation.

The final salary and offer components are subject to additional approvals based on UC policy.

To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)

Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.

For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.

To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html

• Minimum 2 years working on investigator-initiated studies, including, but not limited to, writing consent forms, coordinating development of protocols, and managing timelines for various submissions
• Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system
• Knowledge of UCSF and departmental policies, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology

• Bachelor’s degree in biological sciences, public health, psychology, sociology, or another research-focused discipline and 3+ years of relevant experience; and/or equivalent education and experience in clinical research
• Demonstrated self-discipline and sound, independent judgment completing complex assignments
• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents
• 3 years of experience in clinical research, preferably in compliance/regulatory role
• Minimum 2 years of experience preparing submissions for the Institutional Review Board, the FDA, other regulatory organizations and/or scientific review committees
• Understanding of clinical research methods and operations, the Institutional Review Board, the Food and Drug Administration IND and IDE submission processes and submitted to other research review committees and regulatory bodies
• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents
• Proficiency using computers in a Windows environment, including advanced skills in Microsoft Word and Excel
• Experience applying the following regulations and guidelines: Good Clinical Practice Guidelines; Health Information and Accountability Act (HIPAA); The Protection of Human Research Subjects; CHR regulations for recruitment and consent of research subjects