Cancer Center Jobs

Senior Clinical Trials Regulatory Research Specialist

UC San Diego Moores Cancer Center

October 21, 2022
Reporting to the CTO Administrative Director, the Senior 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/IRB) in order to obtain its approval for the clinical trials to proceed.

The Senior 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).

The position can be fully remote or will work a hybrid schedule which includes a combination of onsite at Moores Cancer Center and remote.

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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.

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.

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.