UCSD Layoff from Career Appointment: Apply by 7/26/17 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Eligible Disability Counseling and Consulting services (DCC) or Special Selection clients should contact their Vocational Rehabilitation Counselor for assistance.
The Clinical Trials Office (CTO) at the Moores UCSD Cancer Center manages over 300 oncology clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.
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.
Extensive knowledge writing and submitting Annual Safety Reports to the FDA.
Demonstrated experience filing Investigational New Drug (IND) Applications to the FDA.
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.
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 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.
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.
Knowledge of cancer research and/or management of oncology cl
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