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MCW: SARGEANT HEALTH CENTER Manager Clinical Research Cancer CTO in MILWAUKEE, Wisconsin

JOB REQUIREMENTS: Position Description: Every great life-changing discovery begins the same way-with new knowledge. It can change everything, from a single life to the future of entire communities. That\'s why academic medicine, and the continuous pursuit of knowledge, is at the center of everything we do at the Medical College of Wisconsin (MCW). In the role of Manager Clinical Research you will beworking in the Cancer Center. Purpose This position is responsible for oversight and management of the Cancer Clinical Trials Office (CTO) Regulatory team in gathering regulatory documents and preparing applications for human subject research to ensure compliance with state, federal and institutional regulations, policies and procedures. The Cancer CTO Regulatory Manager will function as the regulatory liaison with sponsors, principal investigators, study team members, and the IRB, providing support to facilitate the achievement of the Cancer CTO\'s goals. Primary Functions Functional manager representing the Cancer CTO Regulatory Team at meetings with partner organizations as well as internal Cancer CTO process discussions. Works collaboratively with principal investigators, sponsors, study team members as well as representatives in other departments and institutions, maintaining open communication. A resource for investigators and support staff on pre-trial and ongoing trial maintenance functions including gathering of regulatory documents, safety committee reviews, assist with IND applications, IRB applications, trial amendments, annual progress reports, CT.gov applications and maintenance, etc. as specific to clinical trials. Advise department study investigators and support staff on administrative and regulatory aspects of human subject research. Responsible for time, workload and performance management for the regulatory team in the Cancer CTO. Recruit and train clinical research staff on regulatory issues; develop and implement standardized expectations for all subordinates; assess, monitor and evaluate work load and performance. Collaborate with Education/QA Coordinator on the development of training materials. Mentor and direct staff to achieve research goals. Maintain protocol activation timeline including tracking deadlines for program components. Utilize MCW\'s Clinical Trial Management System (CTMS) OnCore and other system to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data. Report program data and progress to program stakeholders Manage other data systems, such as Florence, RightFax, and eBridge which support research activities.... For full info follow application link. EEO/AA Minorities/Females/Vets/Disability The Medical College of Wisconsin is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, veteran status, disability or sexual orientation. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/320571B40BC748D6 Qualified females, minorities, and special disabled veterans and other veterans are encouraged to apply.

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