This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 10/11/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 10/20/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Moores Cancer Center is one of just 51 in the United States to hold a National Cancer Institute (NCI) designation as a Comprehensive Cancer Center. As such, it ranks among the top centers in the nation conducting basic and clinical cancer research, providing advanced patient care and serving the community through outreach and education programs. The Cancer Center's mission is to translate promising scientific discoveries into new and better options for the care of patients with cancer. The Center supports one of the broadest ranges of cancer activities in the nation – from fundamental and translational cancer research in molecular genetics and advanced molecular therapeutics, and from population studies of cancer incidence to community education about cancer prevention and risk reduction.
The Clinical Trials Office (CTO) at UCSD's Moores 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.
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.
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 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.
Knowledge of oncology and hematology.
Working knowledge of UCSD Human Research Protections Program (HRPP/IRB) policies and Procedures.
Must be able to maintain strict confidentiality.
Must be available to work occasional evenings and weekends (may include attending PRMC meetings twice per month, as needed).
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.