Job Description

Payroll Title:
CANCER CENTER/Clinical Trials Office
Salary Range
Commensurate with Experience
Appointment Type:
Appointment Percent:
RX Contract
Total Openings:
Work Schedule:
Days, 8 hrs/day, Monday-Friday

As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.

#119056 Sr. Clinical Trials Regulatory Research Specialist

Extended Review Date: Mon 11/21/2022

UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.

For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy

This position will remain open until a successful candidate has been identified.

UCSD Layoff from Career Appointment: Apply by 10/03/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 10/12/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.

Candidates hired into this position may have the ability to work remotely.


The Clinical Trials Office (CTO) at the Moores UCSD Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators. Reporting to the CTO Administrative Director, the Sr. Clinical Trials Regulatory Research Specialist is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center that require submissions to the Food and Drug Administration (FDA). Key to this role is the development and preparation of clinical trial protocols and related regulatory documents for submission to the FDA and to the UCSD Human Research Protections Program (UCSD's Institutional Review Board or IRB) in order to obtain its approval for the clinical trials to proceed. The Regulatory Research Specialist will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, UCSD IRB, and the CTO. This position requires regular interaction with FDA and a variety of internal and external contacts including Cancer Center investigators and staff, UCSD IRB staff, study sponsors and/or their representatives. Additional responsibilities include making significant contributions to protocol development which consists of two principal functions: (1) Develop clinical protocols in support of the clinical research mission of the Cancer Center and (2) Work with the CTO Executive Director and CTO Administrative Director to provide scientific and regulatory advice to physician scientists. The position will be responsible for the filing with the FDA of necessary documents, including investigational New Drug (IND), Investigational Device Exemptions (IDE) and New Drug Applications (NDA).


  • Theoretical knowledge in a biological science as typically attained by a Bachelor's degree and/or equivalent education and experience. Knowledge of medical and pharmaceutical terminology and concepts, and/or of biological science, sufficient to understand the contents of medical research protocols and research processes.

  • Experience with regulatory issues in clinical research. Direct experience with FDA, NCI, and ICH regulations and guidelines for clinical studies and medical devices, including GCP’s and GMP’s. Knowledge of compliance issues and proven experience in adherence counseling techniques. Knowledge of Federal and University polices on clinical trials and protection of human subjects.

  • Knowledge of clinical trials components including statistics, study methodology, informed consent; eligibility; adverse events. Demonstrated success and skill at researching, analyzing and evaluating information for preparation of clinical research protocols.

  • Extensive knowledge writing and submitting Annual Safety Reports to the FDA.

  • Knowledge of FDA regulations, Institutional Biosafety Committee policy and NIH guidelines as they relate to Investigator Initiated Trials (IIT).

  • Demonstrated experience filing Investigational New Drug (IND) Applications to FDA.

  • Demonstrated experience filing Investigational Device Exemptions (IDE) to the FDA.

  • Extensive knowledge writing and submitting Annual Safety Reports to the FDA.

  • Ability to lead other clinical research specialists to support the growing needs of the cancer center investigators that are performing Investigational New Drug (IND) studies.

  • Experience in data collection, management and analysis, using web tools, relational databases, statistical software and spreadsheets.

  • Knowledge of national and international trends in research and experience with clinical research programs.

  • Demonstrated ability to identify potential sources for program development as well as the ability to prepare appropriate proposals.

  • Thorough understanding of auditing processes in the drug development and approval process. In-depth knowledge and understanding of complex audits that require interpreting regulations, guidelines, and compliance issues. Experience in developing, implementing, evaluating, and documenting audit procedures.

  • Demonstrated ability to make independent decisions, analyze situations, solve problems, and initiate actions for the effective management of a large and complex department. Strong analytical and critical thinking skills to identify problems and develop innovative solutions.

  • Experience in developing long-term goals, initiatives, plans and programs and evaluating accomplishments. Proven ability to develop, analyze, and carry out program and project objectives and work with others in achieving organizational goals. Ability to research, gather and organize information to produce clear and concise reports and presentations using various resources.

  • Strong organizational skills and ability to manage multiple projects with conflicting deadlines and priorities. Ability to meet deadlines. Ability to work with minimal direction and on a self-directed basis as well as in a team setting.

  • Work experience in planning, implementing and evaluating clinical research studies and writing and submitting clinical trials protocols. Industry experience preferred.

  • Substantial experience in performing complex analyses on policies and programs, policies and procedures relating to clinical research.

  • Significant experience writing about science for both technical reviewers and the public as well as writing clinical trials protocols for review committees and regulatory agencies including the National Institutes of Health (NIH).

  • Extensive knowledge of the Code of Federal Regulations that pertain to new drug development.

  • Demonstrated skill in written communications that express complex medical, scientific, and/or technical content in understandable terms. Experienced in proofreading, editing for content, style, flow and tone. Demonstrated ability to write concise, logical, grammatically correct analytical or narrative reports. Demonstrated ability to develop reports and oral presentations.

  • Demonstrated skill is software applications, specifically spreadsheet, word processing and database applications. Knowledge of and experience with clinical database development and data management.

  • Superior interpersonal, written and oral communication skills to effectively communicate, collaborate, establish and maintain good working relationships with a diverse population encompassing multi-disciplinary researchers, faculty and staff about complex research issues. Demonstrated ability to communicate with tact, diplomacy, flexibility, professionalism, and discretion.

  • Demonstrated ability to appropriately handle highly sensitive and confidential situations and matters with faculty and staff.

  • Sound understanding of the role of clinical research in a major research university and its links with campus, national and international constituencies and industry.


  • Bachelor's degree.

  • Knowledge of cancer research and/or management of oncology clinical research trials and clinical trial protocol development experience.


  • Employment is subject to a criminal background check and pre-employment physical.

  • Ability and willingness to travel on occasion (<5%).

Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).

If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.

UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our team!

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community.

UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see:

UC San Diego is a smoke and tobacco free environment. Please visit for more information.

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