Clinical Trials Regulatory Research Associate - 122322

The Moores Cancer Center is one of just 53 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership between the UCSD: encompassing 14 departments (12 clinical, 2 basic sciences), 3 professional schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University, and the basic and translational research of the La Jolla Institute of Immunology.

These various programs and units are all dedicated to fulfilling the Moores Cancer Center's mission of reducing cancer's burden. As such, it ranks among the top centers in the nation conducting the continuum of cancer research, providing advanced patient care, and serving the community through outreach and education programs. As a top-ranking, future-oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. Moores Cancer Center follows a progressive philosophy of career-path development for its employees including opportunities for cross-training, professional development, and progressive responsibility.

MCC's mission is to transform cancer care in our catchment area and beyond by driving exceptional scientific discoveries, and innovations in prevention, detection, care, and training. MCC will make a global impact on improving health by reducing cancer burden through accelerated discovery and translation, compassionate and interdisciplinary care, education and community engagement, with the foundation of our core values - Excellence, Innovation and Risk-Taking, Collaboration, Diversity and Service.

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.

Under the direct supervision of the Project Manager, 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 Clinical Trials 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. This position may assist with study data collection and other duties assigned as needed.

• 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 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.

• 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. Skill at negotiating with various personalities and developing internal and external network of contacts. Ability to maintain confidentiality.

• Experience with editing, including summarizing information into concise and condense documents.

• Experience working and following through on assignments with minimal supervision. Good judgement to know when to ask for assistance from supervisor in cases where regulations and policies & procedures are not clear.

• 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.

• Demonstrated ability to exercise judgment, tact, and firmness in interaction with faculty, students, staff and IRB members, subjects and others.

• 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.

• Knowledge of oncology and hematology.
• Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
• Working knowledge of UCSD Human Research Protections Program (HRPP/IRB) policies and Procedures.
• Experience interpreting medical charts and abstracting data from medical records in relation to study subject screening.
• 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 creating Informed Consent Documents that comply with HRPP/UCSD IRB policies and procedures, FDA regulations, and sponsor requirements.

• Employment is subject to a criminal background check and pre-employment physical.
• 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).