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.
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| Required Qualifications : |
- Bachelor's degree in biological sciences, public health, psychology, sociology, or another research-focused discipline and/or equivalent experience/training.
- Minimum of 3 years of related experience.
- Experience in clinical research to include, but not limited to, protocol editing, clinical research coordination, clinical research associate, regulatory coordinator, and/or clinical research project or program management
- Experience preparing submissions for the Institutional Review Board, the FDA, other regulatory organizations, and/or scientific review committees.
- Experience working on investigator-initiated studies, including, but not limited to, writing consent forms, coordinating the development of protocols and managing timelines for various submissions.
- Understanding of clinical research methods and operations, the Institutional Review Board, the Food and Drug Administration IND and IDE submission processes, NIH RAC submission process, 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.
- Demonstrated self-discipline and sound, independent judgment completing complex assignments.
- Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.
- Proficiency using computers in a Windows environment, including advanced skills in Microsoft Word and Excel.
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| Preferred Qualifications : |
- Master's degree in a research-focused discipline.
- Experience using search engines and writing literature reviews.
- Proficiency with bibliography management software such as EndNote, Papyrus, or Reference Manager.
- UCSF experience.
- Demonstrated proficiency in public speaking and writing.
- Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.
|
| Required Qualifications : |
- Bachelor's degree in biological sciences, public health, psychology, sociology, or another research-focused discipline and/or equivalent experience/training.
- Minimum of 3 years of related experience.
- Experience in clinical research to include, but not limited to, protocol editing, clinical research coordination, clinical research associate, regulatory coordinator, and/or clinical research project or program management
- Experience preparing submissions for the Institutional Review Board, the FDA, other regulatory organizations, and/or scientific review committees.
- Experience working on investigator-initiated studies, including, but not limited to, writing consent forms, coordinating the development of protocols and managing timelines for various submissions.
- Understanding of clinical research methods and operations, the Institutional Review Board, the Food and Drug Administration IND and IDE submission processes, NIH RAC submission process, 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.
- Demonstrated self-discipline and sound, independent judgment completing complex assignments.
- Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.
- Proficiency using computers in a Windows environment, including advanced skills in Microsoft Word and Excel.
|
| Preferred Qualifications : |
- Master's degree in a research-focused discipline.
- Experience using search engines and writing literature reviews.
- Proficiency with bibliography management software such as EndNote, Papyrus, or Reference Manager.
- UCSF experience.
- Demonstrated proficiency in public speaking and writing.
- Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.
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University of California - San Francisco
stock options
Apr 07, 2026