Clinical Research Coordinator III (RN)

About the role

Location: Hematology & Oncology Associates of Fredericksburg. Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work.

Responsibilities

• Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.
• Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures.
• Demonstrate the ability to anticipate and mitigate the potential for protocol non‑compliance.
• Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires.
• Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently.
• Reviews draft informed consent documents in compliance with regulatory requirements and GCPs.
• Conduct an informed consent discussion in compliance with SOPs.
• Review and interpret diagnostic test results and related documentation required per protocol.
• Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events.
• Recognize, report and follow up on all types of adverse events.
• Dispense study medication in a professional and accountable manner following protocol requirements.
• Maintain accurate records of the receipt, inventory, distribution and destruction of study‑related materials / investigational products and research specimens.
• Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations.
• Assesses and manages investigational products that have been compromised.
• Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site.
• Complete all IRB/IEC‑related documents over the course of a clinical study.
• Maintains site credentials and ensures updated GCP, licenses remain on file.
• Comply with reporting of safety related subject discontinuation