University of Wisconsin - Madison

Position Vacancy Listing

PVL # 233744

Position Summary:
The Protocol Administrative Coordinator (PAC) will join the Clinical Research Central Office (CRCO) at the University of Wisconsin Carbone Cancer Center (UWCCC) to work on cancer clinical research within one or more Disease-Oriented Teams. Under the direction of a Clinical Research Pod Manager, the incumbent will maintain knowledge of clinical research principles and specific study guidelines in order to effectively serve as project manager of clinical trial activation, maintenance and closure. The incumbent must have superior oral and written communication skills as they interface with investigators, clinical research staff, study sponsors, and other collaborators to identify, collect and disseminate patient and protocol information. Strong project management, organizational and critical thinking skills are required for success in the complex, fast-paced, highly regulated, and continually changing oncology clinical research environment. The incumbent must be able to handle multiple competing projects simultaneously while working independently using initiative and good judgment.

The School of Medicine and Public Health has a deep and profound commitment to diversity both as an end in itself but, also as a valuable means for eliminating health disparities. As such, we strongly encourage applications from candidates who foster and promote the values of diversity and inclusion.

Principal duties:
Specific responsibilities include, but are not limited to the following:

1) 60% Collaborate with investigators, research staff, hospital departments, and study sponsors to quickly and efficiently move clinical trial research protocols through the activation process. This includes evaluating the protocol to determine necessary resources within and outside the Cancer Center, developing site-specific documents, developing workflows, creating and reviewing treatment order sets, reviewing electronic protocol calendars and IRB applications for accuracy, as well as managing multiple deadlines to ensure the efficient activation of the protocol. The Activation Coordinator is expected to communicate with Principal Investigators, sponsors and site personnel both within and outside the Cancer Center directly to keep all well informed and to ensure the study team is meeting the requirements of the sponsor, institution and study protocol.

2) 20% Work together with investigators, research staff, sponsors and collaborators to maintain clinical trials, which includes reviewing, evaluating and implementing protocol amendments; and assisting investigators and staff to comply with protocol, regulatory, and billing requirements throughout the life of the trial.

3) 10% Prepare for, and liaise with, study sponsors visiting the Cancer Center. These visits may include pre-site visits, site initiation visits and monitoring visits (or audits) conducted by federal, industry, or other institutional sponsors. The Activation Coordinator will schedule, coordinate, and prepare for sponsor visits, ensuring that all study records are available, complete and accurate for
sponsor review. During and following the visits, ensure that all sponsor questions and requests have been adequately addressed.

4) 5% Data management that will include: assisting with the collection, organization and submission of subject data to the sponsor via EDC (Electronic Data Capture) systems. This may also include assisting with CRF (Case Report Form) development, and query management.

5) 5% Perform other duties as assigned to meet the goals of the research program.

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