Every great life-changing discovery begins the same way—with new knowledge. It can change everything, from a single life to the future of entire communities. That’s why academic medicine, and the continuous pursuit of knowledge, is at the center of everything we do at the Medical College of Wisconsin.
In the role of Clinical Research Coordinator I working in Milwaukee, Wisconsin. Our Clinical Research Coordinator I assists 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 of hire
Knowledge – Skills – Abilities
Excellent oral and written communication skills are essential. Proven ability to demonstrate high accuracy and attention to detail as well as sound judgment in a clinical environment with fast-changing priorities. PC database management including data base maintenance, modifications and query/retrieval abilities. Prior experience in clinical setting with focus on medical records and medical terminology as well as data management. Experience with patient contact and/or maintenance of patient confidentiality required. Experience in clinical research including familiarity with diagnostic and medical procedures related to Pediatrics and hematology/oncology preferred.
Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs.