Oncology Research Study Coordinator - SCCC
Categories: Research & Laboratory Support
Department: Simmon CC CRO Rsrch
Full/Part Time/PRN: Full-Time
Experience and Education
Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP), preferred.
1. Serves as primary study coordinator for multiple research protocols. Directs the conduct of multiple clinical studies to ensure adherence to the research protocol and provides weekly updates to Principal Investigator on study progress.
2. Screens patient records, physician's schedules, databases, and physician referral summaries for identification of prospective candidates for research protocols. Interviews prospective subjects for participation in investigations and obtains informed consent. Identifies strategies to improve patient enrollment in research protocols in collaboration with Principal Investigator. Tracks enrollment status of subjects and documents dropout information such as dropout causes and subject contact efforts.
3. Participates in initiation visits/investigator's meetings for assigned clinical trials (may involve travel) and implements these trials according to a deadline schedule mutually agreed upon by PI and sponsor.
4. Develops study working folders for assigned protocols to outline guidelines for protocol compliance and to assure complete source documentation.
5. Educates human subjects for participation in investigations. Educates clinic/hospital personnel for participation in protocol conduct, data collection process, and related conceptual issues as applicable.
6. Coordinates the collection of data according to the research protocol, operations manual, and case report form guidelines within the budgetary guidelines established by the Clinical Research Manager.
7. Directs the requisition, collection, labeling, storage, and shipment of specimens.
8. Performs research related procedures (non-Standard of Care procedures) as directed by study protocol that do not require a licensed medical professional.
9. Instructs Investigators on procedures and tests that need to be performed in compliance with the study protocol and advises Investigators on the results of procedures and tests; calling to attention findings of clinical importance.
10. Documents research related examinations, procedures, tests, and other activities in appropriate clinic or hospital electronic medical records and/or source documents. Completes accurate and complete data entry into case report forms or pre-established electronic or paper data capture systems ensuring appropriate source documentation.
11. Schedules follow-up visits for study patients in collaboration with Principal Investigator and provides source documentation for the activities conducted during these visits.
12. Schedules and undergoes sponsor routine monitor visits and quality assurance audits for periodic reviewing and querying of collected data in a timely fashion.
13. May be responsible for supervision of and delegation of work to clinical research staff.
14. Duties performed may include one or more of the following core functions: (a) Directly interacting with or caring for patients; (b) Directly interacting with or caring for human-subjects research participants; (c) Regularly maintaining, modifying, releasing or similarly affecting patient records (including patient financial records); or (d) Regularly maintaining, modifying, releasing or similarly affecting human-subjects research records.
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