The UCSD Moores Cancer Center (MCC) is one of only 40 National Cancer Institute-designated Comprehensive Cancer Centers in the United States. This designation is reserved for cancer centers with the highest achievements in cancer research, clinical care, education, and community contributions. Moores Cancer Center strives to stay at the forefront of emerging cancer research in a patient centric environment.
Principal Investigators (PIs) in the MCC conduct clinical trials to test new treatments for people affected by cancer. The goal is to find better ways to prevent cancer, treat cancer, and care for cancer patients. The disease teams at the MCC aim to expand the opportunities for advanced therapeutic studies to be written, opened, and maintained, and to increase the number of cancer patients enrolled clinical trials. The focus of the research is cancer symptom intervention studies with an emphasis on novel drug development.
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.
Demonstrated experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Demonstrated 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.
Proficiency 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.
Excellent interpersonal, as well as written and oral communication skills (using grammatically correct written English and accurate typing) to interact with variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy.
Strong administrative and organization skills. Demonstrated experience with editing, including summarizing information into concise and condense documents.
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.
Knowledge or demonstrated related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive.
Flexibility to promote positive working relationships and job effectiveness. Skill at negotiating with various personalities and developing internal and external network of contacts.
- Knowledge of oncology and hematology.
- Working knowledge of UCSD Human Research Protections Program (HRPP/IRB) policies and Procedures.
- Employment is subject to a criminal background check and pre-employment physical.
- Must be available to work occasional evenings and weekends.
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