Responsible for developing, establishing, monitoring, and ensuring on-going compliance to quality standards for the conduct of all cancer clinical research studies within The University of Vermont Cancer Center Clinical Trials Office (UVMCC CTO) and network affiliates. Responsible for developing and implementing a quality management program related to the execution of clinical trials and monitoring adherence to policies and applicable regulations. Assist with the development and implementation of organizational corrective and preventive action plans and Standard Operating Procedures based on internal and external monitoring and audit findings. Responsible for identifying areas needing additional training and education and assisting with the development of those resources. This position will evaluate the effectiveness of the quality assurance program and provide regular updates to the UVMCC CTO Director, Medical Director, and cancer center leadership. Develop and implement a cancer center clinical trials program orientation for new physicians, investigators, research coordinators, and lead cancer clinical trials education initiatives. Conduct quality assurance monitoring to ensure compliance to clinical trials quality standards at UVMCC CTO and network affiliates. They are also responsible for oversight of UVMCC Data and Safety Monitoring Committee (DSMC) operations.

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• Manages regulated human research protocols on assigned board(s) with a minimum of direction; coordinates Institutional Review Board (IRB) member activities; understands and applies federal regulations, state laws, and human research protection program policies to ensure compliance with sponsor and University requirements; analyzes research submissions and provides guidance to principal investigators and research h teams; documents regulatory findings, technical board deliberations and actions; communicates with investigators and assists researchers to secure timely board approvals; continually monitors timelines to avoid delays and approval lapses; indentifies customer service nees; participates in business process improvements and the development of educational programs; may conduct training sessions for research teams and Board members’; relative distribution of duties varies with review board assignment. • Analyzes customer service delivery and participates in development of service innovations; indentifies opportunities to improve and streamline Board and office operations; collaborates with peers and supervisors to develop standard operating procedures; participates in the development and implementation of web-based members; participates in the development of educational materials ; may conduct educational programs for researchers, administrative staff, and board members. • Maintains comprehensive knowledge of federal regulations and guidance, and local policies governing partipation of human subjects in research; pursues professional development; establishes and maintains liaison with principal investigators and researchers coordinators; handles sensitive and confidential information; performs other duties as assigned.

Develop IRB submission packets and communicate with federal sponsors from Clinical Trials Office (CTO) research projects to assure compliance. Review protocol revisions, amendments and updates. Amend protocols, revised clinical trials consent forms and distribute to relevant University protocol holders. Serve as principal contact from the CTO for the Institutional Review Board (IRB). Provide regulatory updates to the OSU Director

* Communicates and coordinates with personnel in the clinical, laboratory, contracts, leadership and information & logistics groups in relation to international site preparedness, protocol implementation activities and other activities of the International Program.* Serves as a key resource for other Operations Center personnel about the International Program* Initiates and Participates in Activities to Improve the Overall Quality of Work at the Operations Center* Maintains open and ongoing communication with the International Program Manager, International Program Specialists, and other Operations Center staff to proactively identify barriers and resolve issues related to the accomplishment of International Program objectives.* Suggests mechanisms to improve Operations Center support for the International Program.* Generates ideas and facilitates initiation of activities within the Operations Center to improve work processes.

! Scheduled and arranged Foreign Service employee language training sessions. ! Coordinated and managed overseas mission assignments and travel arrangements for Foreign Service officers. ! Provided general human resources assistance to government Foreign Service employees

! Provided nutrition education to various community outreach programs. ! Designed and prepared nutrition cooking demonstrations for WIC participants. ! Prepared nutritional lesson plans for WIC participants and community outreach programs. ! Conducted seminars on healthy eating habits for over 30 parents (a monthly optional meeting for individuals enrolled in the WIC program).

! Compiled and organized patient information into corresponding medical records. ! Recorded data from cardiovascular films for research analysis and surgical procedures. ! Prepared clinical trial information for the FDA. ! Assisted in patient transport to the operating room for surgical procedures.