The North Carolina Translational and Clinical Sciences (TraCS) Institute, supported by the NIH Clinical Translational Science Award, provides the infrastructure to support research at UNC-CH. The Regulatory Knowledge and Support Component of TraCS serves as the central regulatory information resource for investigators and their research teams and enhances protection of human research subjects by providing integrated training and guidance for investigators and study team members. The goal of the Regulatory Knowledge and Support Component is to ensure that all clinical research activities conducted through TraCS are performed in compliance with applicable laws, regulations, guidelines and institutional requirements.
The Protocol and Quality Assurance Specialist is responsible for providing protocol development and quality assurance support and monitoring services to investigators at UNC and institutional partners involved in TraCS initiated research. The Specialist serves as a subject matter expert for TraCS and the UNC research community on regulatory requirements, obligations and responsibilities that govern the conduct of clinical, social/behavioral and interventional research. The Specialist provides faculty with consultation and assistance navigating regulations, as well as direct assistance in developing comprehensive and compliant study protocols. Additionally, the Specialist will conduct quality assurance monitoring for studies led by UNC PIs. The Specialist works closely with the UNC office of Clinical Trials, Clinical Research Support Office (CRSO), Office of Human Research Ethics (OHRE) and RTI International to ensure proper oversight of human subjects research, to assure regulatory compliance and to develop and provide training for investigators at the university conducting human subjects research.
The position requires substantial capacity to independently manage and coordinate activities in a complex environment. The Specialist will have excellent interpersonal /management skills as the position will require substantial communication and coordination with a variety of individuals.
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