JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: Under the direction of the Senior Associate Dean of Research, this position has administrative and strategic oversight of the UTHSC Cancer Center and other areas in the COM clinical research infrastructure. Incumbent works collaboratively with Principal Investigators, departments, and several offices within and external to the UTHSC to facilitate protocol review, budgetary development, and financial management of clinical trials. This position serves as the University's Head Clinical Research Coordinator (CRC) for the SWOG Cancer Research Network.
DUTIES AND RESPONSIBILITIES:
Provides administrative and regulatory oversight for the review of clinical trial protocols to determine programmatic and financial feasibility for participation.
Prepares the annual PI local context submission to National Cancer Institute (NCI), Central IRB (CIRB) which includes NCI CIRB study submissions and UTHSC IRB study submissions and Clinical Trial support Unit (CTSU) study registrations.
Ensures COM compliance with SWOG, CTSU, NIH NCI requirements.
Observes regulations for federally-funded studies, including current human use regulations; including 45 CFR 46 and 2 CFR 200 Uniform Administrative Requirements for Grants and Contracts.
Provides administrative services for management of cooperative studies (SWOG and NRG) by serving as the Head Clinical Research Coordinator (CRC) for the university.
Conducts SWOG training for required staff and facilitates SWOG and NCI audits of member and affiliate sites.
Facilitates annual NCI Investigator registrations, annual CTEP-IAM PI and research staff registrations, and SWOG Investigator registrations.
Travels to bi-annual group meeting and study portfolio management meetings with participating physician-investigators.
Ensures regulatory compliance by facilitating SWOG and NCI audits; manages private health information (PHI) and other patient related issues.
Resolves regulatory affairs issues, concerns, or complaints, as deemed necessary.
Serves as subject-matter expert on clinical trials in the COM and develops standard operating procedures (SOPs) and COM policies.
Performs other related duties as assigned.
Internal Number: 212506
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.