Clinical Research Coordinator I – Regulatory

Position Description:

Purpose

Member of the Cancer Center CTO Research Regulatory team 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. This CTO Research Regulatory Specialist will function as a regulatory liaison with sponsors, principal investigators, study team members, and the IRB providing support to facilitate the achievement of the Cancer Center CTO’s goals.

Work Location: Will be onsite for the first 2 months and then will allow for 100% virtual work. Must work within a state that MCW is an employer: Wisconsin, Michigan, Missouri, Minnesota, Arizona (Exempt only), Illinois (Exempt only), Florida

Primary Functions

• Prepare the required documents in the MCW/Froedtert electronic IRB system for initial approval, amendments, and continuing progress reports.  Review for accuracy and completeness, identify problems and perform quality control based on established checklists prior to IRB submission
• Working knowledge of e-Bridge, electronic IRB, and Grants and Contracts functions
• Works collaboratively with principal investigators, sponsors, study team members as well as representatives in other departments and institutions while maintaining open communication.
• Recruit, screen, enroll and obtain 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.
• Collect, analyze, and disseminate program data.  Report program data and progress to program stakeholders.
• Coordinate notifications to study team members regarding annual regulatory education requirements
• Coordinate program outreach activities including acting as a liaison with community organizations, and providing regulatory support for Community Memorial Hospital/St. Joseph’s Cancer Center in West Bend, and others as applicable.
• Identify problems or obstacles in the system/procedures related to the implementation of the research protocols and communicate to the study investigators.
• Assure compliance with all relevant IRB and other regulatory agency requirements.
• Assist in the preparation of IRB documents and reports. Assist in the evaluation and writing of research protocols.
• Collaborate on the development of program materials including educational materials, marketing materials, websites, forms, and reports.
• Work with Principle Investigator to develop, implement, and maintain comprehensive databases and files related to the program.
• Maintain program timeline including tracking deadlines for program components. Utilize MCW’s Clinical Trial Management System (CTMS) to assist with meeting regulatory requirements and tracking activities. Collect, analyze, and disseminate program data.  Report program data and progress to program stakeholders.
• Coordinate program outreach activities including acting as a liaison with community organizations.

Knowledge – Skills – Abilities

Excellent oral and written communication skills are essential.  Strong critical thinking, problem-solving, and attentiveness to detail are required. Additional training in regulatory compliance is strongly preferred.

Preferred Schedule:

Full-time, 8-4:30

Position Requirements:

Specifications

Appropriate education and/or experience may be substituted on an equivalent basis

Why MCW?

• Outstanding Healthcare Coverage, including but not limited to Health, Vision, and Dental. Along with Flexible Spending options
• 403B Retirement Package
• Competitive Vacation and Paid Holidays offered
• Tuition Reimbursement
• On-campus Fitness Facility, offering onsite classes.
• Additional discounted rates on things such as select cell phone plans, local fitness facilities, Milwaukee recreation, entertainment, etc.

For a full list of positions see: www.mcw.edu/careers  

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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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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