This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 04/25/19 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 05/06/19. 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 policies on clinical trials and protection of human subjects.
Knowledge of clinical trials components including statistics, study methodology, informed consent; eligibility; adverse events. Proven 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 and Investigational Device Exemptions (IDE) to the FDA.
Proven work experience in planning, implementing and evaluating clinical research studies and writing and submitting clinical trials protocols.
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.
Substantial experience in performing complex analyses on policies and programs, policies and procedures relating to clinical research.
Extensive knowledge of the Code of Federal Regulations that pertain to new drug development. 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, i
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