UCSD Layoff from Career Appointment: Apply by 09/18/20 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 09/30/20. Eligible Special Selection clients should contact their Disability Counselor for assistance.
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, fellows and postdocs and 480 staff personnel.
The Clinical Research Coordinator will coordinate and oversee 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 agencies for the purpose of implementation of studies. The Clinical Research Coordinator will plan, develop and implement start-up procedures for multiple phase I-III research studies in assigned disease team as well as lead, direct, and coordinator operational efforts. 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. Independently create original documents and policies for assigned disease teams. Work closely with federal and state regulatory officials.Oversee Clinical Trials Administration and Regulatory compliance, coordination and documentation of specified pharmaceutical and device clinical trials and protocols. Responsible for development of protocols and execution of procedures.
Responsible for ensuring that all procedures comply with regulatory procedures and standard operating procedures. Design case report forms for PI initiated and Sponsor provided protocols. Responsibilities include the development and maintenance of all study related documents and procedures for the FDA, CRO and Pharmaceutical Company; oversee execution of protocols to be conducted at the site; and coordinate, assign, and evaluate the activities of in-house coordinating staff to ensure FDA Compliance and Good Clinical Practice. This position will require developing, updating and refining of Standard Operating Procedures. Additionally, responsible for study recruitment, including the innovation of screening process to improve patient and clinical trial databases. Responsible for performing protocol defined procedures as required. Independently collect and analyze scientific data for publication, identify and develop new clinical trial protocols, train and monitor research staff, medical students, fellows, hospital nurses assigned to these protocols. Incumbent is required to use Velos, a mandatory clinical trials management system that is used to track all patients enrolled in a clinical trial, track all scheduled visits and individual events performed at each visit and is used for studies that have a conventional care coverage analysis.
Strong theoretical knowledge and/or Bachelor's Degree in a social science or basic science such as Biology, Microbiology or a related field; and/or an equivalent combination of education and work experience.
Demonstrated experience in clinical trials research. Strong knowledge of experimental protocols, data gathering, protocol design and evaluation.
Proven experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Strong experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.
Strong knowledge of investigational protocols (data management, query resolution, protocol design and protocol implementation).
Proven experience performing clinical research duties in a clinical research environment such as CRO, academic research institution, and/or a research hospital.
Demonstrated experience in providing work direction and assisting supervisor in maintaining an efficient medical research team.
Strong knowledge of investigational protocols especially with pediatric cardiology protocols (data management, query resolution, protocol design, protocol writing and protocol implementation).
Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
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.