Position Description:
Summary Assist clinical research staff by providing administrative and data collection support for clinical studies. Primary Responsibilities
- Under the direction of the Manager of Clinical Research, study coordinator, research nurse, and Principal Investigator, the CRA III will work collaboratively to support clinical trials available to the division from cooperative groups, industry sponsors, and investigator-initiated trials.
- Ensure compliance with sponsoring organization's guidelines, as well as with relevant policies and procedures from FDA, IRB, Children's Wisconsin, and Medical College of Wisconsin
- Coordinate subject recruitment with disease-based teammates, including: providing clinical team members with appropriate documentation for obtaining informed consent, confirming eligibility, and submitting necessary documentation to lead protocol organization to enroll eligible subjects to registry and banking studies, primarily, and others as necessary.
- Coordinate the collection, processing, and shipment of biologic specimens in keeping with protocol guidelines.
- Report research data accurately and in timeframes called for by protocol. Resolve any data queries that are posed by the sponsor or the sponsor's representatives in timeframes called for by the protocol.
- Assist study coordinators with preparations for specimen collection, processing, packaging, and shipment.
- Coordinate with study coordinators, research nurse, clinical staff to ensure informed consent is obtained at necessary timepoints after enrollment (i.e. upon reaching age of majority, in response to new safety information).
- Work with supervisor to identify problems or obstacles in the system/procedures related to implementation of research protocols.
- Provide support as needed to back up clinical research functions including patient enrollments, informed consents, and facilitate/coordinate clinical research activities designated by protocols and maintain appropriate clinical research data records.
- Perform other duties as assigned.
Knowledge - Skills - Abilities
- Excellent oral and written communication skills are essential.
- Knowledge of biology, chemistry, mathematics, documentation, and records management.
- Data utilization, complex problem solving, critical thinking and resource management.
Preferred Schedule:
Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs.
Position Requirements:
Minimum Required Education: High School Diploma Minimum Required Experience: 1 year Preferred Education: Bachelor's Degree Preferred Experience: 3 years, 1 of which is in clinical research, medical, or similar support Required Certification/Licensure(s): CITI training within 90 days of hire #LI-NI1
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 an inclusive 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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Medical College of Wisconsin
Aug 19, 2025