Clinical Research Coordinator III
 Medical College of Wisconsin | |||
 United States, Wisconsin, Milwaukee | |||
 Jul 23, 2025 | |||
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Clinical Research Coordinator III/Regulatory Specialist-IRB Purpose Responsible for gathering regulatory documents, preparing IRB applications, amendments and continuing review for human subject research ensuring compliance with Federal, State and Institutional Standard Operating Procedures. In the regulatory specialist capacity, will function as the regulatory liaison with sponsors, principal investigators, study team members and the IRB providing support to facilitate the achievement of the research team goals. Coordinate the day-to-day administrative activities of the clinical research trials program. Provide support to the team to facilitate the achievement of the program's goals. Recruit, train, and supervise staff and manage study budgets. Primary Functions - Clinical Research Coordinator III - * Oversee the recruitment, screening, enrolling and obtaining of consent from program participants. Conduct or coordinate training for program participants. * Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants. * Oversee the collection, analysis, and dissemination of research data. Report program data and progress to study investigators. Develop, implement and maintain comprehensive databases and files related to the program. * Identify problems or obstacles in the system/procedures related to implementation of the research protocols and communicate to the study investigators. * Assure compliance with all relevant IRB and other regulatory agency requirements. * Prepare IRB documents and reports. Evaluate and write of research protocols in collaboration with the study investigator. * Coordinate and manage program outreach activities including acting as a liaison with community organizations. * Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports. * Manage program timeline including tracking deadlines for program components. * Coordinate and manage program outreach activities including acting as a liaison with community organizations. Organize internal and external meetings, site visits, and special events. * Manage study related budgets and provide reports as required to department administration and funding agencies. Participate in the development of program resources through literature searches, contact with outside programs, and review of funding opportunities Research Regulatory Specialist -
Knowledge of biology, chemistry, mathematics, documentation, and records management. Excellent oral and written communication skills are essential. Strong critical thinking, problem solving and attentiveness to detail required. Additional training in regulatory compliance strongly preferred. Data utilization, complex problem solving, critical thinking, resource management, and writing skills.
Specifications Appropriate experience may be substituted on equivalent basis Minimum Required Education: Bachelor's Degree Minimum Required Experience: 5 years Certification: CITI training within 90 days of hire. SoCRA and ACRP certification preferred.
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