Investigator Initiated Trials (IIT) Specialist

Helen Diller Family Comprehensive Cancer Center (HDFCCC)

Full Time

87276BR

Job Summary

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

Department Description

The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.

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.

About UCSF

The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells.

Pride Values

UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values.

In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu

Join us to find a rewarding career contributing to improving healthcare worldwide.

Equal Employment Opportunity

The University of California is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, protected veteran status, or other protected status under state or federal law.

Organization

Campus

Job Code and Payroll Title

005269 RSCH CMPLNC ANL 3 RP

Job Category

Compliance and Privacy, Research and Scientific

Bargaining Unit

Research and Public Service Professionals (RP)

Employee Class

Career

Percentage

100%

Location

San Francisco, CA

Campus

Mission Bay (SF)

Work Style

Flexible

Shift

Days

Shift Length

8 Hours

Additional Shift Details

Monday - Friday; 40 hour/week