Regulatory Specialist | University of California San Francisco - Military Veterans

The Department of Orthopaedic Surgery is looking for a candidate experienced in high volume clinical trials, protocol development, and regulatory submissions to work with investigators to prepare, submit, provide guidance, and manage the regulatory submissions. for a large portfolio of Investigator Initiated Trials as well as Sponsored Projects. Under the direction of the Research Administration and Operations Director, and in compliance with University and Department policies and federal and state regulations, this individual will work closely with investigators, their study teams, regulatory personnel, and sponsor partners to draft and manage study documents and regulatory submissions for new and existing studies in the department. The successful candidate will have experience working with clinical trials and their Principal Investigators (PIs), reviewing, and developing clinical trial protocols and consent forms, and have experience submitting to regulatory agencies, including IRB and FDA submissions. Previous experience working on a clinical trial team is a preferred. General responsibilities of the Investigator Initiated Trials Protocol Development and Regulatory Specialist include: 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