Sr. Clinical Trials Regulatory Research Specialist
University of California, San Diego
Location: La Jolla, California
Internal Number: 111513
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 09/07/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 09/15/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
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.
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.
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.
Experience in developing long-term goals, initiatives, plans and programs and evaluating accomplishments. Ability to develop, analyze, and carry out program and project objecti
UC San Diego is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.