Clinical Research Coordinator I

Medical College of Wisconsin•Milwaukee, WI

About The Position

Perform day-to-day administrative activities for the clinical research trials program and support the team in achieving its goals. The coordinator works with multiple Principal Investigators to ensure proper conduct of assigned Clinical Trials Office trials at Children’s Hospital of Wisconsin, keeps study leaders informed, and manages day-to-day priorities. The role coordinates participant recruitment and research protocols, collects and reports study data, supports regulatory compliance and documentation, and contributes to program materials, databases, timelines, and outreach. The position may also involve processing and shipping lab specimens.

Requirements

  • Associate's degree.
  • At least 1 year of experience.
  • CITI and GCP training within 90 days of hire.
  • Knowledge of biology, chemistry, mathematics, documentation, and records management.
  • Skills in data utilization, complex problem solving, critical thinking, resource management, and writing.
  • Ability to obtain IATA certification within 30 days of hire.
  • Appropriate experience may be substituted for education on an equivalent basis.

Nice To Haves

  • Familiarity with the EPIC electronic medical record system.
  • Familiarity with clinical trial management systems; proficiency with OnCore is preferred.

Responsibilities

  • Work with multiple Principal Investigators to ensure proper conduct of assigned Clinical Trials Office trials at Children’s Hospital of Wisconsin.
  • Maintain regular contact and provide updates when necessary.
  • Work with Clinical Trials Office leads and managers day to day, providing updates and managing priorities.
  • Screen, recruit, enroll, and obtain consent from study participants.
  • Coordinate research protocols, including arranging appointments and procedures, collaborating with other departments and institutions, and maintaining contact with study participants.
  • Collect, analyze, and disseminate study data.
  • Report data and progress to Principal Investigators and CTSI stakeholders.
  • Identify system or procedural problems and obstacles related to implementation of research protocols and communicate them to study investigators.
  • Ensure compliance with applicable IRB, HIPAA, GCP, and other regulatory requirements.
  • Maintain ongoing training, certifications, and compliance with current regulations at MCW, CHW, and VA.
  • Assist with preparation of IRB documents and reports.
  • Assist in evaluating and writing research protocols.
  • Collaborate on developing study materials, including educational and marketing materials, websites, forms, and reports.
  • Work with the Principal Investigator to develop, implement, and maintain comprehensive program databases and files.
  • Maintain the program timeline and track deadlines for program components.
  • Coordinate program outreach activities, including serving as a liaison with community organizations.
  • Process and ship lab specimens as necessary.

Benefits

  • Health, vision, and dental coverage.
  • Flexible Spending options.
  • 403B retirement package.
  • Competitive vacation and paid holidays.
  • Tuition reimbursement.
  • Paid parental leave.
  • Employee and Family Assistance Program (EFAP).
  • Pet insurance.
  • On-campus fitness facility with onsite classes.
  • Discounted rates on select cell phone plans, local fitness facilities, and Milwaukee recreation and entertainment.
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