Research Compliance Analyst IV - Cancer Center
The University of California, San Diego
About this position
Position Description
The Moores Cancer Center (MCC) 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 28 departments, 6 schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health, Jacobs School of Engineering, School of Biological Sciences & the School of Physical Sciences), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University (SDSU), and the basic and translational research of the La Jolla Institute of Immunology (LJI). 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 accelerateddiscovery 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 general direction of the Assistant Director, Quality Assurance, the incumbent provides advanced-level regulatory compliance oversight and quality assurance support for oncology clinical research operations within the Moores Cancer Center Clinical Trials Office (CTO). The position is responsible for evaluating and monitoring clinical research activities involving regulatory documentation, investigational pharmacy practices, participant protections, and protocol conduct to ensure compliance with federal regulations, institutional policies, sponsor requirements, Good Clinical Practice (GCP), and protocol-specific standards. Applies advanced research compliance expertise to interpret and implement highly complex oncology research regulations, policies, and guidelines across multiple therapeutic areas, sponsors, and trial phases. Independently analyzes and resolves complex compliance issues involving informed consent, eligibility verification, investigational product accountability, adverse event reporting, protocol deviations, participant safety, and regulatory submissions. Exercises substantial judgment in identifying compliance risks, assessing operational vulnerabilities, determining appropriate corrective and preventive actions, and promoting audit and inspection readiness. Serves as a senior technical resource and advisor to leadership, investigators, research staff, and ancillary departments on oncology clinical research compliance matters. Provides expert guidance on regulatory requirements, documentation standards, investigational pharmacy operations, participant-facing processes, and research quality oversight to support the ethical conduct of clinical trials, safeguard research participants, and strengthen program-wide research integrity.
Qualifications
Nine years of related experience, education/training, OR a Bachelor’s degree in related area plus five years of related experience/training. Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments. Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents. Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology. Strong proficiency in public speaking, and writing. Knowledge of federal, state, and institutional regulations governing human subjects research. Advanced experience with supporting FDA submissions, such as IND, IDE, and/or 510(K), including pre submission documentation. Advanced experience in HHS, OHRP, FDA, HIPAA, GCP, IND/IDE processes, and clinical research regulatory requirements. Ability to execute core research compliance tasks, such as independently reviewing protocols, conducting quality reviews, and investigating non-compliance.