Clinical Research Manager

3 days ago

Milwaukee, Wisconsin, United States Medical College of Wisconsin Full time
Job Title: Clinical Research Manager

Join the Medical College of Wisconsin (MCW) team as a Clinical Research Manager in the Cancer Center. As a key member of our research team, you will be responsible for overseeing the Cancer Clinical Trials Office (CTO) Regulatory team in gathering regulatory documents and preparing applications for human subject research.

Key Responsibilities:
  • Functional manager representing the Cancer CTO Regulatory Team at meetings with partner organizations and internal Cancer CTO process discussions.
  • Works collaboratively with principal investigators, sponsors, study team members, and the IRB to facilitate the achievement of the Cancer CTO's goals.
  • Responsible for time, workload, and performance management for the regulatory team in the Cancer CTO.
  • Recruit and train clinical research staff on regulatory issues and develop standardized expectations for all subordinates.
  • Maintain protocol activation timeline, track deadlines for program components, and utilize MCW's Clinical Trial Management System (CTMS) OnCore and other systems to assist with meeting regulatory requirements.
  • Collect, analyze, and disseminate program data, report program data and progress to program stakeholders, and manage other data systems such as Florence, RightFax, and eBridge.
  • Develop and implement Cancer CTO departmental policies, procedures, and organizational tools to ensure compliance with MCW institutional standard operating procedures and procedural guidelines, state, and federal standards.
  • Act as a liaison between Department Administrator and research staff, work closely with other departments and external agencies to advance the department's research goals, and develop, implement, and monitor department research QI activities.
Requirements:
  • Bachelor's degree in a related field.
  • 6 years of experience in research program coordination or regulatory.
  • CCRC or CCRP certification required, CITI training required within 90 days of hire.
Why MCW?

MCW offers a competitive benefits package, including health, vision, and dental coverage, 403B retirement package, tuition reimbursement, paid parental leave, pet insurance, and on-campus fitness facility. We are committed to fostering a diverse community of outstanding faculty, staff, and students and ensuring equal educational opportunity, employment, and access to services, programs, and activities without regard to an individual's race, color, national origin, religion, age, disability, sex, gender identity/expression, sexual orientation, marital status, pregnancy, predisposing genetic characteristic, or military status.

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