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Clinical Research Coordinator I - Pediatric Hematology/Oncology/Bone Marrow Transplant

Medical College of Wisconsin

Last Updated: 8/31/21

Job Description

We’re looking for those individuals—the creative thinkers and innovation seekers—who are content with nothing short of changing the world. Discover the endless opportunities within the Medical College of Wisconsin and be inspired by the work we can do together to improve health, and make a positive, daily impact in our communities.

In the role of Clinical Research Coordinator I working in Milwaukee, Wisconsin. The Clinical Research Coordinator assists in the organization and conduct of clinical trials in pediatric Oncology, Bone Marrow Transplant and Hematology. Focusing on non-therapeutics, psychology, and survivorship 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.

Responsibilities:

  1. Work collaboratively to support clinical trials available to the division from consortia and cooperative groups as well as industry sponsors and investigator-initiated trials
  2. Ensure compliance with sponsoring organizations’ guidelines, as well as with relevant policies and procedures from FDA, IRB, Children’s Wisconsin, & Medical College of Wisconsin.
  3. Coordinate subject recruitment with disease-based teammates, including providing clinical team members with appropriate documents for obtaining informed consent, assist in 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.
  4. Work collaboratively with disease-based teammates to assess, track, and report adverse events, including serious adverse events, in keeping with protocol requirements.
  5. 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.
  6. 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.
  7. Work with Clinical Research Coordinator III to identify problems or obstacles in the system/procedures related to implementation of the research protocols.
  8. Perform other duties as assigned.


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 Qualifications:

  • Appropriate education and/or experience may be substituted on equivalent basis
  • Minimum Required Education: Associate degree
  • Minimum Required Experience: 1 year
  • 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.

Why MCW?

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.


About MCW
The Medical College of Wisconsin (MCW) is one of the largest healthcare employers in Wisconsin. We are a distinguished leader and innovator in the education and development of the next generation of physicians, scientists, pharmacists and health professionals; we discover and translate new knowledge in the biomedical and health sciences; we provide cutting-edge, collaborative patient care of the highest quality; and we improve the health of the communities we serve.

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.



Company Details

Milwaukee, Wisconsin, United States