UCSD Layoff from Career Appointment: Apply by 08/14/18 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Eligible Disability Counseling and Consulting services (DCC) or Special Selection clients should contact their Vocational Rehabilitation Counselor for assistance.
The UCSD Moores Cancer Center (MCC) is one of only 49 National Cancer Institute-designated Comprehensive Cancer Centers in the United States. This designation is reserved for cancer centers with the highest achievements in cancer research, clinical care, education, and community contributions. Moores Cancer Center strives to stay at the forefront of emerging cancer research in a patient-centric environment. Their Clinical Trials Office provides diagnosis and management of benign and malignant tumors for inpatient and outpatient cases, offering access to novel therapeutics.
Reporting directly to the Associate Administrative Director, the incumbent coordinates the clinical research efforts of the Moores UCSD Cancer Center Clinical Trials Office. Responsible for coordinating and managing clinical trial activity conducted at the North County Cancer Centers including Encinitas and Vista locations; this includes: providing all aspects of protocol oversight, including but not limited to screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug/therapy reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files.
Coordinate development of cooperative group affiliation including credentialing and coordination of training. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Oversee research protocol writing, start-up procedures, implementation, recruitment, and close out procedures. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards as assigned. Provide direct assistance to the Research Director in reviewing and verifying research account statements, professional fee statements, and invoicing. Coordinate research efforts with the Moores Cancer Center team through close communication and collaboration with the Associate Administrative Director.
The incumbent acts as a liaison with other departments and community clinics/agencies for the purpose of implementation of studies. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Work closely with federal and state regulatory officials.
A Bachelor's Degree or advanced theoretical knowledge in a social science or basic science such as Biology, Microbiology or a related field; and/or equivalent work experience.
Proven experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures.
Demonstrated experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.
Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management. Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
Demonstrated experience interpreting medical charts and abstracting data from medical records.
Strong knowledge of investigational protocols especially with radiation oncology protocols (data management, query resolution, protocol design, protocol writing, evaluation, and protocol implementation). Working knowledge of medical and scientific terminology.
Demonstrated experience working with FDA policies regulating clinical trials.
Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.
Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
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.