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The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.
Reporting directly to director of cardiovascular clinical research. Responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing.
Under supervision, the Clinical Research Coordinator Ast. will be assigned to coordinate multiple federally funded and industry sponsored research studies involving human subjects that are being conducted in the UCSD Cardiovascular Institute and at other local locations. Assist with initiation, implementation and management of clinical trials. Ensure compliance with goals and objectives of research protocols and with state and federal regulatory guidelines. Duties include but not limited to: interpreting research protocols; recruiting subjects; screening for eligibility including obtaining vital signs, ECGs, height and weight; monitoring and timely reporting of adverse events; toxicities and protocol deviations; scheduling subjects' visits; coordinating clinical, laboratory and data activities; processing and submitting laboratory specimens; collecting and entering research data; maintaining accurate and complete clinical research files and patient medical charts.
Update study and patient records in the University approved Clinical Trial Management System (VELOS) on a consistent basis. Working directly with Human Research Protection Program (HRPP), submitting new protocol applications, amendments, safety reports and annual renewals, as needed. Act as liaison between the Principal Investigators, the HRPP and study sponsors.
Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's Degree; or an equivalent combination of education and experience.
Demonstrated experience performing clinical research duties in a clinical research environment.
Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.
Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
Demonstrated experience working with FDA policies regulating clinical trials.
Proven experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
Proven experience maintaining files and keeping records. Experience completing clinical trials case report forms via hard copy and online.
Demonstrated experience interpreting medical charts, experience in abstracting data from medical records.
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.
Demonstrated experience with clinical trials participant or study subject recruitment.
Demonstrated experience coordinating study startup activities.
Experience providing in-service training to various research personnel on protocols, processes, and procedures.
Thorough knowledge of x-rays, scans, and other diagnostic procedures.
Strong planning and organizational skills. Ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet
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