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

Position Description:

Summary

Assist in the organization and conduct of clinical trials in pediatric Oncology, Bone Marrow Transplant and Hematology. Focus is 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.

Primary Responsibilities

• Work collaboratively to support clinical trials available to the division from consortia and cooperative groups as well as industry sponsors and investigator-initiated trials Coordinate research protocols including arranging necessary appointments and procedures, working collaboratively with other departments and institutions, and maintaining contact with study participants.
• 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, 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.
  • 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 queires that are posed by the sponsor or the sponsor's representatives in timeframes called for by the protocol.
  • Work collaboratively 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 direct supervisor to identify problems or obstacles in the system/procedures related to implementation of the 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.
  • Assist in study start up processes by scheduling Site Evaluation Visits and Site Initiation Visits.
  • Independently manage regulatory submissions to the Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), Office of Clinical Research and Innovative Care Compliance (OCRICC) and the Data Safety Monitoring Committee (DSMC).
  • Administer protocol-specific training to disease-based teammates.
  • Perform other duties as assigned.

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.

Preferred Schedule:



Full-time role with expectations for coverage during core business hours and flexibility required as necessary to accommodate business needs.

Position Requirements:

Qualifications

Appropriate experience may be substituted on equivalent basis.

Minimum Required Education: Associate's Degree

Minimum Required Experience: 1 year

Preferred Education: Bachelor's Degree

Preferred Experience: 2 years

Required Certification/Licensure(s): CITI training within 90 days of hire

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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 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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