Description
Summary: Collaborates with departmental leadership and research staff in the coordination of all aspects of clinical research studies. Responsibilities include: patient screening and recruitment, coordination of care of the research patient, protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB). Coordinates studies in Oncology therapeutic areas. Functions independently in a clinical research setting and responsible for the complete coordination of assigned clinical research protocols from national research agencies and pharmaceutical corporations.
Responsibilities:
1. Screens patients for study participation e.g. reviews medical record, collaborates with medical & research staff, etc. and procures informed consent.
2. Maintains accurate and thorough documentation on all source documents and case report forms (CRFs) for each study patient. Resolves all patient queries.
3. Maintains communication with investigators/researchers, patients, internal and external collaborators (e.g. consulting physicians), sponsors, federal regulatory agencies, and other involved parties as required.
4. Participates in investigator, coordinator, or study initiation meetings accordingly. Coordinates and participates in monitoring visits/audits with regulatory agencies or sponsors.
5. Maintains current regulatory (GCP, HSR) and study specific required trainings.
6. Prepares and submits all study protocols, consent forms, and other required documents to the Institutional Review Board (IRB).
7. Educates hospital staff about protocols through in-services, written materials and one-on-one interaction, for each study and each patient, and for general marketing.
8. Demonstrates flexibility in daily routine and effectively accommodates for the needs of the job (e.g. early or late patient enrollment).
9. Performs procedures including EKG, Phlebotomy, blood and body fluid sampling, packing and shipment of human samples, body measurements and examinations within scope of practice and training, consistent with clinic and study specific policies/procedures and scope of care under the guidance of the supervisor.
10. Fulfills all compliance responsibilities related to the position.
11. Maintain and Model Nuvance Health Values.
12. Demonstrates regular, reliable and predictable attendance.
13. Performs other duties as required.
Other Information:
Salary Range: $29.65 - $55.55 hourly (Pay based on years of relative experience)