"Investigator Initiated Trials (IIT) Specialist"

Under the direction of the Protocol Development Manager, and in compliance with University and HDFCCC policies and federal and state regulations, the IIT Specialist 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 IITs.

The successful candidate will have experience working with clinical trials and their Principal Investigators (PIs), reviewing and developing clinical trial protocols and consent forms, preferably in oncology, and have experience submitting to regulatory agencies, including IRB and FDA submissions. Previous experience working on a clinical trial team, utilizing Microsoft Word document editing tools, and project management experience is 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, and 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.

The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement.

The salary range for this position is $81,300 - $172,300 (Annual Rate).

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