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 incumbent independently oversees and manages research protocols for their assigned disease team in the Clinical Trials Office (CTO). Coordinate and oversee research start-up procedures, implementation, recruitment, screening, enrollment, and maintenance of subjects. Create informational and recruitment materials and act as a liaison with other UCSD departments and community clinics/agencies for the purpose of implementation of studies.
The Oncology Project Manager will work closely with Principal Investigators to analyze scientific data and propose new related clinical protocols. The incumbent will oversee the development of new clinical protocols; provide work direction and supervision to clinical operations staff. Manage all aspects of the Disease Team team clinical research operations including clinical trial implementation and execution, quality and compliance, and strategic planning and project management. The Project Manager will coordinate multiple Disease Team clinical trials at various stages of development, implementation, and close out. They will manage the clinical research activities for physicians and supporting research staff working at various UCSD locations, serve as the project director of each protocol, and build a collaborative research team focused on the efficient performance of clinical trials. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction to the team and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Independently create original documents and policies for the team.
Work closely with federal and state regulatory officials. Prepare, analyze, and negotiate Disease Team clinical trials budgets in assigned disease areas. Make important original contributions and innovative ideas pertaining to the strategies and methodologies used in preparing complex scientific clinical research studies. Organize, analyze and interpret complex, medical, scientific and/or technical data and contribute substantively in the development of scientific writing of protocols as well as proposals, including participation in Disease Team clinical research, methods, research design, measurement, intervention and analysis. Additional responsibilities include management and prioritization of queries from Industry, Moores Cancer Center Administration, and from individual PIs. Responsible for protocol development and management of phase I, II, and III clinical trials in patients with advanced illness. Participate in research grant opportunities and draft grant proposals as required. Supervises staff involved in routine research study coordination. Receives predetermined work assignments that are subject to a moderate level of control and review. Oversees staff in execution of assignments; trains and mentors staff to improve quality and quantity of work.
Seven (7) years of related experience, education/training, OR a Bachelor's degree in related area plus three (3) years of related experience/training.
Knowledge of clinical trials components including statistics, study methodology, informed consent; eligibility; adverse events. Proven success and skill at researching, analyzing and evaluating information for preparation of clinical research protocols.
Strong experience in Clinical Trials and Clinical Trials Program Management. Hands-on experience with Industry sponsored trials, cooperative group trials, and/or investigator initiated trials.
Working knowledge of clinical or laboratory research, clinical trial recruitment, eligibility, protocol adherence, quality data submission and adverse event reporting.
Strong knowledge and experience of the clinical research coordinator and regulatory associate roles.
Demonstrated knowledge of regulatory submissions and compliance.
Proven experience managing project budgets including monitoring expenses, creating and analyzing projections, auditing fiscal reports, and providing status reports. Knowledge of accounting as applied to both University and Medical Center functions. Knowledge of medical billing and collections guidelines and procedures.
Demonstrated skills in employee supervision and HR administration. Proven experience in training others, particularly in the field of research.
Ability to effectively manage multiple priorities, prioritize projects and meet the demands of a fast-paced and dynamic work environment. Adaptable to quickly changing priorities.
Demonstrated ability to successfully create and negotiate clinical trial budgets.
Critical thinking skills to evaluate issues and identify a potential solution.
Clear and concise communicator; good verbal and written communication skills; both.
Good interpersonal skills, including but not limited to: problem-solving, teamwork development, leadership, mentorship. Skills to effectively motivate others. Works well with others to achieve common goals. Ability to cultivate relationships with multiple stakeholders at various levels of administration.
Ability to perform all commonly applicable functions in word processing and spreadsheet software. Effectively uses campus' clinical information and documentation application programs. Proven ability utilizing clinical trial management systems.
- Knowledge or experience with oncology research and terminology.
- Advanced degree and/or SoCRA or ACRP Certification
- Employment is subject to a criminal background check and pre-employment physical.
Apply on company website