Req Number 38235BR
Job Title Clinical Trial Study Coordinator
Job Code and Payroll Title 7236: ANALYST III
Job Code and Payroll Title 7236 ANALYST III
Location Parnassus Avenue
Department Name Pediatrics
Work Days 9am - 6pm, days to be determined
Shift Length 8 Hours
Job Summary Under the direction of the Principal Investigator, the incumbent will be the lead study coordinator for at least 2 clinical research studies in type 1 diabetes to preserve insulin producing beta cells, while overseeing and mentoring more junior clinical research team members and assisting in other related projects. One study will be a phase 1 effort evaluating the safety of infusion of regulatory T cells, and the other will be a multi-center phase 2 trial with an immuno-modulatory drug. UCSF will be the lead center for both of these studies. In partnership with the PI, the incumbent will assume a leadership role on all aspects of these clinical trials, from development of the protocol and trial design, and establishing a manual of operations and standard operating procedures; to understanding and compliance within the protocol and manual of operations and standard operating procedures; and coordination with the Clinical Research Center; to development and implementation of a data base to capture and analyze results gathered from the trial. Further responsibilities include, but are not limited to: recruitment, scheduling and supervision of study subject enrollments; administering questionnaires; developing consent forms; management of CRC protocol adherence; HIPAA regulatory documents; clinical research budgetary items; patient care recharges and reconciliation; gathering lab results; follow-up histories; abstracting patient records; management and safe handling of remote blood sampling ,including collecting, processing, storing, and freezer maintenance f serum samples; management of research data; database maintenance and entry; training, completion and preparation of case report forms and other documents for shipment to the study sponsors; organizing events where mass screenings of relatives of type 1 diabetics occur; and development of a recruitment network among health care professionals in Northern California, and perform other duties as needed. The incumbent will also prepare Committee on Human Research (CHR) applications, modifications and renewals. The incumbent will be responsible for Adverse Event Reporting to the CHR, and will compose and provide documents for the study sponsor.
Aside from the primary aspects of these two clinical trials as delineated above, the incumbent will join a larger clinical diabetes research team that is conducting related trials in type 1 diabetes and endocrinology. The incumbent will have a leadership role on this team, serving as a resource for other team members, helping to cross cover trials, and reviewing common issues that arise for the group in conduct of trials and developing best practices to optimize group function. The incumbent will work closely with other physicians, study coordinators, and nursing staff in our clinical research group, as well as a recruitment coordinator. The incumbent will train new study coordinators as new clinical trials are anticipated to start in the next few months, and will work with the PI to review new studies, and determine which are most appropriate for our group to participate in. The incumbent will help with the ground work necessary to then help move these studies forward, including communication between the study sponsor and UCSF contracts and grants, help with review of study budgeting, and determining how such studies will become operational and staffed by the group; incumbent will also perform other duties as assigned.
Required Qualifications . BA/BS with a major in Biological Sciences and at least three years minimum experience in administrative analysis or operations research; or an equivalent combination of education and experience;
. Extensive experience and knowledge of clinical trial recruitment, eligibility, protocol adherence, data submission and adverse event reporting.
. Relevant clinical/basic research experience, especially data collection with a high degree of complexity;
. Excellent organizational, detail oriented and communication skills with CHR committee and Laboratory Staff
. Able to meet multiple deadlines for concurrent projects; project management experience or experience in executing a research protocol
. Experience in preparing documents for review by the Committee on Human Research and the study sponsor
. Excellent interpersonal skills and ability to work with a clinical trial team in an academic setting
. Extensive knowledge of clinical trial recruitment, eligibility, protocol adherence, data submission and adverse event reporting.
. Ability to prioritize and work independently
. Computer literacy in working complex database for study visit reporting; Macintosh and/or PC computer experience; Excel, MS Word required
. Experience with Phase 1,2, and 3 clinical trials
. Physical Demands: requires bending, squatting, climbing stairs, reaching up to shoulder height; pushing/pulling up to 60 pounds; sitting, standing, walking, waist twisting, kneeling; carrying/lifting 0-20 pounds; gripping/grasping, fine/gross finger manipulation; repetitive movements of upper extremities; may be exposed to latex; differentiate color; use protective equipment; differentiate color; operate motor vehicle.
Note: Fingerprinting and background check required.
Preferred Qualifications . RN/BS in Nursing
. Knowledge of investments, investment accounting and investment pool processing.
. Prior experience with banking and investment transactions.
Position Type Full Time