JOBSUMMARY/ESSENTIAL JOB FUNCTIONS: Under an assigned director, thisposition manages three related highly complex duties to assistinvestigator in complying with relevant federal regulations, state laws, andinstitutional policies related to the conduct of clinical research and inproperly documenting compliance with those requirements Ensures thetimely reporting of adverse events or other unanticipated problems and addressspecific concerns identified by the IRB Chair or Director, conduct audits at UTHSC,affiliated institutions, and routine internal audits of the IRB. The threecomponents of this role are: (1) reviewing investigator records,dental/medical records, IRB records; monitoring ongoing research to ensureadherence to study procedures as described in study protocol and informedconsent document; observing the consent process; and interviewinginvestigators, staff and subjects, (2) developing customer satisfaction andneeds assessment instruments and analyzing the results in order to identifyeducational need so the university's researchers and client institutionsregarding regulatory requirements and navigation of IRB application forms andprocesses, and (3) developing and implementing training programs and materialsto meet identified educational needs. Audits and other activities may beconducted at UTHSC and at each of the affiliated institutions.
Completes comprehensive reviews of IRB records, investigator study records, and patient medical/dental records when applicable.
Reviews, analyzes, and interprets the application of federal and state laws, regulations, institutional policies and guidelines to protect human subjects and ensures institutional compliance.
Monitors onsite research to determine adequacy of research facilities, studies staff and the protection of human subjects; observes the consent process from initiation to documentation of the subject's consent, and interviews investigator's staff and/or subjects.
Provides regulatory, ethical, and method assistance to investigators, staff, and student researchers as applicable to specific audited studies.
Develops customer satisfaction instruments and analyze results; identifies educational needs of researchers based on the results of survey instruments, and develops strategies for meeting those needs.
Identifies protocols to be audited (random/routine and for cause) through review of ongoing clinical trials (enrollment status, risk/benefit ratio, reported adverse events, regulatory issues, etc.); conducts routine internal audits of IRB, including an evaluation of written policies, procedures, databases, file records, and overall efficiency.
Develops and prepares reports when audits are completed and findings are analyzed; assists in the reporting of serious or continuing non-compliance issues to government and institutional official; conducts appropriate follow up to ensure deficiencies are corrected in a timely manner.
Ensures the timely reporting of adverse events or other unanticipated problems and address specific concerns identified by the IRB Chair or Director.
Provides assistance and instruction to Board members, faculty, staff, student researchers and study/research coordinators regarding use of the IRB electronic system and IRB submissions.
Performs other related duties assigned.
Internal Number: 180666
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.