#81916 Clinical Trials Regulatory Research Associate
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POST DATE 9/3/2016
END DATE 11/25/2016
University of California - San Diego Medical Centers
San Diego, CA
JOB DESCRIPTIONThis position will remain open until filled.
UCSD Layoff from Career Appointment or Special Selection: Apply by 05/16/16 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Eligible ACCES or Special Selection clients should contact their Vocational Rehabilitation Counselor for Special Selection.
Established in 1978, UC San Diego Moores Cancer Center is one of just 41 National Cancer Institute-designated Comprehensive Cancer Centers in the United States, and the only one in the San Diego region. Such centers are prominent among the leading institutions in the nation dedicated to scientific innovation and clinical excellence. This designation reserved for centers with the highest achievements in cancer research, clinical care, education and community contributions makes an enormous difference to our patients. Studies show that outcomes are better at NCI-designated centers.
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. The Clinical Trials Regulatory Research Associate is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center. Key to this role is the preparation of clinical trial protocols and related regulatory documents for submission 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 Associate 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 a variety of internal and external contacts including Cancer Center investigators and staff, UCSD IRB staff, study sponsors and/or their representatives.
Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge and/or Bachelor's Degree; and/or equivalent education and/or experience in a field related to biological sciences as needed to work in Regulatory Affairs.
Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Experience creating Informed Consent Documents that comply with HRPP/UCSD IRB policies and procedures, FDA regulations, and sponsor requirements.
Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheet, New Study Applications, Renewal Applications, IND Applications, etc. Experience preparing, reviewing, and understanding clinical research protocols and protocol amendments.
Experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports.
Experience developing and maintaining record management systems. Strong administrative and organization skills, experience prioritizing assignments when faced with a heavy workload and competing deadlines.
Skill at negotiating with various personalities and developing internal and external network of contacts.
Proven ability to determine sources of information and data, and to analyze the data and information obtained, in order to create documents and to propose solutions to issues. Detail oriented, logical, and methodological approach to problem solving.
Excellent interpersonal, as well as written and oral communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness.
Knowledge of Oncology and Hematology.
Must be able to maintain strict confidentiality.
Must successfully complete pre-employment physical and annual TB screen.
Must be available to work occasional evenings and weekends (may include attending PRMC meetings twice per month, as needed).