University of Wisconsin - Madison

Position Vacancy Listing

PVL # 233526

Position Summary:
The Project Manager will join the Chemoprevention Disease-Oriented Team (DOT) and report directly to the Chemoprevention Program Manager at the University of Wisconsin Carbone Cancer Center (UWCCC). The Chemoprevention Disease-Oriented Team (DOT) participates in Phase I, II and III oncology prevention clinical research funded by national, federal and private sponsors. The selected candidate must demonstrate strong oral and written communication skills and an ability to work with patients, health care providers, external institutions and the study sponsors. The incumbent will work independently and as part of a group on multiple projects simultaneously, prioritizing projects based on deadlines and interdisciplinary collaboration.

Work experience should demonstrate dependability, flexibility, and maturity. Candidates must be effective at building interpersonal relationships with constructive interactions, be clear and effective communicators, promote and create collegial environments that value accountability. Employees will be expected to uphold UWCCC core values as defined below:

Respect: Demonstrate respect for self and others--behave professionally.
Integrity: Act with Integrity and honesty.
Teamwork: Commit to and demonstrate teamwork.
Excellence: Ensure excellence, quality, and high ethical standards in conduct and performance.

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) Protocol Development (20%) -Collaborate on the design and development of research protocols. This includes completing assigned sections of the research protocol and informed consent form to be used within a research project, responding to review questions from the sponsor or other review committees and incorporating changes to the research protocol or informed consent form. Update research protocol and informed consent form when amendments are required and submit other study-related documents per sponsor's request.

2) Database Development and Management (15%) - Collaborate with investigators, sponsors and statisticians as needed to develop protocol defined data collection elements. Responsibilities for this include organizing the data collection elements by means of a System Variable Attribute Report (SVAR) or Case Report Forms (CRF), responding to reviews from the sponsor or other study team members and incorporating changes. Once finalized, work with the database team to construct the database to contain the needed data collection elements. Also, collect and organize data to be entered in the database and ensure that it is consistent for each participant on the research study.

3) External Institution Management (40%) - Serve as the point of contact for external institutions participating in the clinical research study. Responsibilities include disseminating study documents to the sites that include protocol, informed consent form, recruitment materials, source documentation and any other study-related guidance. In addition, the incumbent will conduct site initiation visits and train the sites on the research protocol, assist with the collecting and processing of regulatory documents and submissions, assist with research reporting of protocol deviations and Serious Adverse Events and review screening materials to determine eligibility of external institutions' participants for the research study.

4) Monitoring and compliance (15%) - Review the data submitted by the external institutions and monitor it for completeness and accuracy. This person will be responsible for reviewing and querying research data in real-time and submitting the queries to the external institutions for corrections.

5) Study Activation and Closure (10%) - Assist with study activation and closure procedures. For study activation, this includes: Working with our central services (regulatory and calendar builders), as well as, work with TRIP, Biobank, CP lab and PRC to activate the research study. Collaborate with investigators, research staff, hospital departments and sponsors to assist with the development, implementation and evaluation of research studies. For study closure, this includes: management of all research samples both locally and at the external institutions, locking the database and conducting a close out visit at all external institutions. In addition, prepare for a close out visit to be performed locally.

7) Form and maintain good working relationships with faculty and staff from external institutions along with the study sponsor in conducting research under the consortium contract. Participate in Think Tank and training conference calls with the study sponsors. Conduct protocol-specific conference calls with the external institutions and the Study sponsor, as well as, assist with the collection of contract-mandated deliverables to the study sponsors.

8) The Project Manager will provide clinic backup for colleagues and be responsible for additional projects and responsibilities as designated by the Program Manager.

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