Coordinator, Research Study

Summary

• Position Summary
  • The Coordinator Research Study is responsible for the conduction of research activities. Ensures that research is conducted in accord with the stipulations of the sponsor by working with the clinical investigators to assist in the process of enrolling patients, ordering specific tests, performing vital signs, EKGs and other assessment procedures as able within compliance to SJ/C policies, and collecting and recording data for clinical research protocols. Coordinates all components of data collection and patient enrollment in various types of patients and disease entities, which are subject of the clinical investigator, numerous protocols simultaneously ensuring assigns protocols are consistent with Good Clinical Practice (GCP), Federal Food and Drug Administration (FDA), and local organizations. Maintains open communications and is available to component organizations and practitioner sites for consultation.
• Education
  • Associates in Healthcare - Required
• Experience
  • 2-3 Years Clinical research with Oncology experience - Preferred
• License & Certification
  • Professional License with State of Practice - Required
  • National certification in current specialty within 18 months of hire upon eligibility.
• Core Job Functions
  • Identify, screen and enroll patients to clinical trials per established goals. Ensure appropriate patient per inclusion/exclusion criteria. Schedule follow up visits and clinical tests and discuss with applicable investigator(s).
  • Coordinate patient's physical assessment by the PI and ensure modification of study treatment per protocol is overseen by the PI and/or CRC under supervision of the investigator. Monitor patients throughout trial for all untoward reactions and communicate to PI.
  • Assist in completion of screening/subject enrollment tracking logs and resolution of queries. Order tests and submit data within required timeframe.
  • Assist with the reporting of Serious Adverse Events, Progress Reports, revised Informed Consents, Amendments, Investigator Brochures, and Safety Reports to the IRB as needed. Maintain necessary supplies for study/infusion therapy, including medications and study/medical supplies. Audit Outcomes Acceptable/Acceptable with Follow Up.
  • Monitor and facilitate patient compliance with medication, maintain pharmacy study drug binders and ensure drug accountability maintained for assigned protocols (zero drug discrepancies or documentation supporting otherwise).