JOBSUMMARY/ESSENTIAL JOB FUNCTIONS: Under the direction of the medicaldirector and director of research, this position promotes good clinicalpractices on behalf of plastic surgery clinical trials by possessing in-depthknowledge of federal regulations.
Assists with ensuring all ongoing or anticipated clinical studies and related activities are performed according to federal regulations, as well as university and sponsoring agency policies and procedures.
Reviews and develops a familiarity with the study protocols (i.e. study proceedings and timelines, inclusion and exclusion of criteria, confidentiality, etc.).
Assists the medical director with communicating study requirements to all individuals involved.
Screens subjects for eligibility.
Prepares study material, as requested.
Maintains regulatory documents, prepares protocols, handles consent forms for submission to the UT IRB Office for initial and ongoing reviews.
Ensures study participants are safe and fully informed.
Performs clinical work-ups and follow-ups with patients as indicated by study protocols.
Serves as clinical liaison between clinical studies and others involved in projects including patients, physicians, nurses, data collectors, and evaluators.
Maintains documents related to clinical trials and human participant protection.
Assures compliance with protocol and regulatory requirements, manages patient protocol activities, assures patient safety, collects records, and maintains data and source documentation.
Assists the residents and fellows in the collection of data and manuscript preparation.
Performs other related duties as assigned.
Internal Number: 182429
The mission of the University of Tennessee Health Science Center is to bring the benefits of the health sciences to the achievement and maintenance of human health, with a focus on the citizens of Tennessee and the region, by pursuing an integrated program of education, research, clinical care, and public service.