Clinical Research Coordinator

Summary

• Position Summary
  • The Clinical Research Coordinator (CRC) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI) on ongoing research studies. The CRC is responsible for facilitation and coordination of the daily clinical trial activities associated with all Cancer Care Delivery Research (CCDR) and cancer control clinical trials as directed by the Manager of the Oncology Clinical Research department. They may also assist with non-treatment and Quality of Life studies as appropriate. In general, the CRC is responsible for ensuring full compliance with the protocol, applicable regulations (e.g., FDA policies), and Good Clinical Practice (GCP) and Institutional Review Board (IRB) requirements. The CRC should have some experience in a healthcare setting and be familiar with the standard concepts, practices, and procedures within the clinical oncology research field. Responsibilities of the CRC may include but are not limited to: screening medical charts to identify potential patients for protocol eligibility, participating in the informed consent process, coordinating patient schedules to comply with protocol requirements, recruiting and registering study participants, data collection and data entry. In addition, the CRC may participate in the review of prospective clinical trial protocols for site feasibility. This individual should demonstrate the ability to work as part of a team as well as independently under general supervision.
• Education
  • Bachelor' degree - Preferred
• Experience
  • 2-3 Years Oncology experience - Preferred
  • 1 Year Clinical Research experience - Preferred
• License & Certification
  • Certified Clinical Research Coordinator Certification (CCRC) - Preferred
  • Certification required to be obtained after 2 years of employment
• Core Job Functions
  • Monitor study activities for assigned protocols to ensure compliance with study requirements as well as local, federal, state, and institutional regulatory policies. Maintains all documents and records related to study activities including case report forms, source documents, pharmacy drug binders, and regulatory documents.
  • Assess eligibility of potential subjects using a variety of methods such as the review of medical records and discussions with physicians and Advanced Practice Providers. Be actively involved in patient recruitment by discussing potential subjects with investigators, approaching candidates in the office or speaking to them by phone, asking pre-screening eligibility questions, reviewing the trial with the patient, and conducting informed consent with the patient.
  • Schedule and oversee participant visits and any required tests and/or imagining according to the protocol. Ensure visits, tests, and imaging appointments are scheduled within the appropriate window and completed at each required timepoint. Monitor and facilitate patient compliance with medication and ensure drug accountability is maintained for assigned protocols.
  • Monitor subjects per protocol requirements and ensure that the modification of study treatment is overseen by the investigator and/or CRC under the supervision of the investigator. Monitor patients throughout the trial for all untoward reactions and communicate immediately to the investigator.
  • Document and report adverse events, ensuring review and follow-up by the treating physician. Monitor patient care and treatment side-effects together with the investigator while keeping detailed documentation for reporting and source documentation.
  • Responsible for the collection, processing, preparation, and shipping of laboratory specimens. 
  • Collect participant data, enter data in appropriate databases, and resolve data queries in a timely manner.