Position Description:

Position Summary

Position: Clinical Research Coordinator II

Purpose

Perform the day-to-day administrative activities of Clinical Trial's Office (CTO) for the Department of Medicine (DOM). Work closely with team and leadership on trial management. Provide support to the team to facilitate the achievement of the DOM CTO's goals. Assist with trial management, onboarding, and training of research staff, faculty, and learners.

Primary Functions

• Conduct or coordinate training for program participants.
• Collect, analyze, and disseminate research data. Report study related data and progress to study to management, study investigators, and sponsors are required. Work with Principal Investigator to 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 and study team. Conduct and coordinate training for investigative team.
• Prepare and submit IRB documents and reports. Assure compliance with all relevant IRB and other regulatory agency requirements.
• Monitor study related activities on a patient, protocol and financial level including budget negotiations.
• Collaborate on the development of Department processes and documentation including educational materials, marketing materials, websites, forms, and reports.
• Maintain timelines including tracking deadlines for individual research projects.
• Participate in the development of CTO resources through literature searches, contact with outside programs, and review of funding opportunities.
• Facilitate monitoring and audit related activities.
• Assist with study start-up and with multi-site trials. Process and ship lab specimens, as necessary. Recruit, screen, enroll and obtain consent from program participants.
• Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments, ancillary partners and institutions, and maintaining contact with study participants.
• Maintain patient calendars, screening and enrollment information while utilizing the OnCore and Florence software tool to assist in patient specific protocol required timelines to ensure compliance with protocol requirements.

Preferred Schedule:
Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs.

Position Requirements:

Knowledge - Skills - Abilities

• Experience in research or study coordination and/or compliance. Knowledgeable of federal, state, local and other regulatory requirements that involve clinical trials or grants.
• Strong interpersonal and facilitation skills to work effectively with stakeholders from multiple organizations, to include leading meetings, and coordinating study activities.
• Has good judgment and analytical ability to problem solve and make decisions, formulate reports, perform statistical analysis and interpret data, create and monitor work plans, prioritize workload, and meet deadlines.
• Customer focused, organized. builds trust, and has strong communication, critical thinking, and influencing skills.

Specifications

Appropriate experience may be substituted for education on an equivalent basis

Minimum Required Education: Bachelor's degree in relevant field

Minimum Required Experience: 2 years of experience in research

Certification: CITI training required within 90 days of hire. CCRP or CCRC preferred

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MCW as an Equal Opportunity Employer and Commitment to Non-Discrimination
The Medical College of Wisconsin (MCW) is an Equal Opportunity Employer. We are committed to fostering a diverse community of outstanding faculty, staff, and students, as well as 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. Employees, students, applicants or other members of the MCW community (including but not limited to vendors, visitors, and guests) may not be subjected to harassment that is prohibited by law or treated adversely or retaliated against based upon a protected characteristic.

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