|The Research Specialist will support the University of Wisconsin Regional Coordinating Center (UW-RCC) for stroke clinical trials and the Department of Neurological Surgery clinical trials. Under the guidance of the Principal Investigators and Research Program Manager, the Research Specialist will also assist with the outreach and research activities of the UW-RCC and department, including the coordination of clinical research trials.
Specific duties will include:
50% Regional Coordinating Center
- Work closely with the PI's and Regional Research Networks Coordinator in study site initiation and implementation procedures.
- Assist Outreach Specialist with training and assisting coordinators at other sites with study data collection, entry and analysis as needed
- Serve as research coordinator and/or coordinator contact for RCC clinical trials as assigned. Role may include the recruitment of potential clinical study participants, verification of subject eligibility, performing and/or facilitating study procedures (e.g. diagnostic tests, radiology tests, lab test collection and processing), data collection and entry, and other protocol-specific requirements for some projects and serving as one of the research coordinator contact to regional sites.
- Maintain knowledge of current active protocols and protocols in progress.
- Maintain protocol regulatory documentation and tracking personnel training documentation.
- Assist with tracking subject payments and setup of study-specific requisitions.
- Assist with the clinical research protocols/proposals including, but not limited to, applications to the Health Sciences IRB and regional IRBs, WiNHR, and the National IRB for this network.
- Assist in the development of source documents and case report forms and integration of required data variables into ONCORE-CRM or other clinical trial data management system. Serve as initial contact for data management questions or troubleshooting.
- Assist with RCC standard operating procedure implementation and monitoring.
- Participate in compliance and quality improvement related activities as assigned.
- Scheduling of RCC teleconferences, face to face meetings, and other conferences including facility reservations, assisting with writing agendas and minutes, and other associated duties.
- Communicate effectively with internal and external stakeholders in assisting with the development and implementation of clinical research projects across multiple sites.
- Assist in developing Oncore protocols for each protocol, communicate and problem solve arrow questions from partnering sites throughout the region.
- May require evening and weekend call
- Other related duties as assigned.
50% Department of Neurological Surgery Clinical Research
- Identify and recruit potential research study subjects and verify subject eligibility in accordance with the various population health research protocols inclusion and exclusion criteria
- Obtain informed consent from research subjects while abiding by all applicable human subjects protections laws and policies.
- When necessary, monitor research subjects' progress to ensure compliance with study endpoints. Review laboratory, radiology, and pathology results to ensure multiple population health research protocol compliance.
- Maintain working knowledge of current active population health research protocols within the department
- Collect and record outcomes as related to research study participation. Accurately and efficiently retrieve data from source documents and research interviews/surveys. Maintain research subject records, including documentation of changes in investigational drug doses, changes in other medications used by study participants, overall health status of study participants, and occurrence of drug related side-effects
- Maintain a working knowledge of Health Link and Departmental databases as they relate to open population health research protocols
- When necessary, assist in preparation for external monitors and audits. In preparation for monitor visits conducted by sponsors, evaluate completeness of data in medical records and assist monitors during site visits by providing verification of population health research protocols compliance
- Assist research program manager in the review, preparation, and submission of new research protocols for approval to the Health Sciences IRB, the Clinical and Translational Research Core (CTRC), and the Research and Development Committee-William S. Middleton Veteran's Hospital
- Ensure that at all times, required regulator components of the study are completed and filed appropriately. Create, maintain, and update study files throughout the duration of the project.