Clinical Research Nurse Coordinator

Opportunity to join a NCI designated comprehensive cancer center as a clinical research nurse. Prior research coordination and RN required for this role. The ideal candidate will have prior experience within the oncology space.

Description:

• Manages and organizes assigned site studies. Serves as the primary organizer for assigned trials between University staff, hospital staff, CROs, Investigational Drug Service, Clinical Research Support laboratory, diagnostic radiology, Clinical Trial Tissue Services, Review Board and others involved in the conduct and oversight of human clinical research.
• Tracks and reports adverse events, serious adverse events, protocol waivers, deviations and violations. Assists investigators in the preparation of corrective action plans and ensures implementation and adherence to stated plan.
• Documents and conveys study data. Supervises assigned staff to ensure that report forms are accurately documented and completed in a timely manner at each site location.
• Assists in ensuring principal investigator oversight by providing updates on protocol issues, obtaining signatures and clinical significance on lab reports, ECGs, adverse events and other documents as required.
• Designs and implements quality control measures to ensure accurate collection and processing of data.
• Abstracts concomitant medications from medical records.
• Maintains a high degree of knowledge on regulatory and policy requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements. Develops, implements, and manages internal practices that ensure compliance with federal requirements.
• Organizes and performs all research activities within the highest ethical, legal and scientific standards in accordance with federal, state and institutional regulatory requirements and policies.
• Participates in interim monitoring visits, internal audits and external audits/inspections.
• Monitors and audits follow-up letters, observation reports and other information to ensure all action items are responded to prior to the next scheduled interim monitoring visit.