Clinical Trials Coordinator
Department: Urology - 414101
Vacancy ID: P008505
Position Summary: The Urology Clinical Trials Coordinator will be responsible for overseeing clinical trials activity within the Department of Urology. The Urology Clinical Trials Coordinator must: organize and plan work operations within the group, administer clinical trials and projects, manage human resource related items as needed, and develop procedures and policies for the group. The Coordinator will also help develop/maintain a clinical trials portfolio and serve as a clinical resource within the clinical trials group. This position reports directly to the Medical Director of Clinical Trials and will supervise any future staff hired to support the clinical trials mission for the Department. This position will ensure that compliance standards are met on all trials; he/she will negotiate with the sponsors and have a good financial understanding of the trials; and he/she will ensure that we maintain accurate records and capture necessary data to enable timely invoicing and payment reconciliation. The Coordinator will have expertise in IRB and will ensure compliance and timely processing. As coordinator, this person coordinates and conducts complex aspects of multiple industry, federal (NIH) and faculty initiated research activities supported by the Department of Urology. The Coordinator will work closely with the Medical Director Clinical Trials and Department's Principle Investigators to achieve study goals within the required timeframe. Guidelines for each clinical trial are developed by the sponsoring agency and approved by the University of North Carolina. The role of the Urology Clinical Trials Coordinator is central to the success of the trial in managing participant recruitment, ensuring timely achievement of milestones, timely and accurate data submission and adherence to protocol. Additionally, the Coordinator will uphold standards of good clinical practice and abide by mandates established by the University's Office of Human Clinical Research. Once a study is deemed appropriate for consideration, the Coordinator will review protocol and budget, working with the supervisor and Pl to determine feasibility and areas for negotiation. When a commitment is made to begin the study, the Coordinator ensures an efficient prep phase and begins to enroll participants as soon as possible. Due to the nature of these studies, participant screening requires timely review of the medical record, interpretation of lab results and clinical findings, knowledge of the disease process studied and coordination with multiple physicians and other members of the care team. The Coordinator becomes the primary point of contact for the participant (in regards to the study) and must instill confidence, be able to answer specific questions, and know when medical guidance or contact is required. The Coordinator is responsible for recruitment of patients, coordination of visits, data collection, recording and submission.
Application Deadline: 06/22/2018
Qualification and Experience: Licensed to practice as a Registered Nurse in the State of North Carolina and two years of experience in the area of specialization.
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