The Medical College of Wisconsin brings a synergy between the best medical education, research and patient care. Tomorrow’s discoveries happen right here alongside the very people who bring those lessons to our students. Every bit of knowledge, and every advancement, provides our students with an unprecedented, collaborative learning environment, and helps improve the vitality and care of our communities.
In the MCW/Children’s Wisconsin partnership, there’s no greater priority than the care of our kids. Just as every child is unique, the approaches we take in their healthcare must be equally so. By creating new approaches in patient care, discovering leading-edge advances in biotechnology and developing effective educational programs for students, residents, fellows and faculty, the Department of Pediatrics at the Medical College of Wisconsin is proving why we’re among the best. Whether it’s out in the community addressing health disparities of underserved children or in the lab creating gene therapies or tumor vaccines to enhance survival of children with life threatening illnesses, MCW focuses on all aspects of advancing knowledge for the benefit of kids.
In the role of Clinical Research Coordinator I working in Milwaukee, Wisconsin. Our Clinic Research Coordinator will assist in the organization and conduct of clinical trials in pediatric Oncology, Bone Marrow Transplant and Hematology. Focus is on phase II & III interventional, supporting care, and banking trials. This position manages source documentation, data reporting to sponsors, and protocol compliance. This position assists in subject recruitment, audit preparation (internal & external audits), & reporting to IRB and FDA.
- Work collaboratively to support clinical trials available to the division from consortia and cooperative groups as well as industry sponsors and investigator-initiated trials
- Ensure compliance with sponsoring organizations’ guidelines, as well as with relevant policies and procedures from FDA, IRB, Children’s Wisconsin, & Medical College of Wisconsin.
- Coordinate subject recruitment with disease-based teammates, including: providing clinical team members with appropriate documents for obtaining informed consent, determining tests and procedures required to determine subject eligibility, and submitting necessary documentation to lead protocol organization to enroll eligible subjects.
- Coordinate the collection, processing, and shipment of biologic specimens in keeping with protocol guidelines.
- Work collaboratively with disease-based teammates to assess, track, and report adverse events, including serious adverse events, in keeping with protocol requirements.
- 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.
- Work collaborative with disease-based teammates to ensure protocol-directed observations, procedures, and therapy are performed in accordance with the protocol. When protocol-directed observations, procedures, or therapy are not performed in accordance with the protocol ensure that such deviations are documented in keeping with regulatory obligations.
- Work with Clinical Research Coordinator III to identify problems or obstacles in the system/procedures related to implementation of the research protocols.
- Perform other duties as assigned.
- Certification: CITI training within 90 days
Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs.
Appropriate experience may be substituted for education on an equivalent basis
* Minimum Required Education: Associate degree
* Minimum Required Experience: 1 year
- Outstanding Healthcare Coverage, including but not limited to Health, Vison, 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 as: Select cell phone plans, local fitness facilities, Milwaukee recreation and 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.
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.