Essential Duties

1. Manages and organizes assigned site studies. Serves as the primary organizer for assigned trials between University staff, Yale-New Haven Hospital staff, non-Yale collaborators, Sponsors, CROs, Investigational Drug Service, Clinical Research Support laboratory, diagnostic radiology, Clinical Trial Tissue Services, Yale Institutional Review Board and others involved in the conduct and oversight of human clinical research. 2. 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. 3. 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. 4. 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. 5. Designs and implements quality control measures to ensure accurate collection and processing of data. 6. Ensures adherence to protocol for all study participants throughout the duration of participation in the clinical trial. Identifies instances of noncompliance and deviations from protocol and reports noncompliance and deviations to the appropriate parties. Assists investigators and Clinical Trial Managers in the preparation and execution of corrective and preventative action plans. 7.  Abstracts concomitant medications from medical records. 8.  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. 9. Monitors federal and state regulations for new guidance, updates, or policies. 10. 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. 11. Participates in interim monitoring visits, internal audits and external audits/inspections. 12. 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. 13. Serves as a resource and provides technical assistance to investigators and their staff. 14. Provides analytical and technical support related to establishing and recording protocol congruency. 15. Performs other duties as assigned.

About Yale University Cancer Center Clinical Trials Office

Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer, and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention, and patient care, as well as community outreach and education. The Clinical Trials Office is in a period of rapid growth and actively recruiting Clinical Research Coordinators. They will be responsible for planning, tracking, and ensuring that the clinical activities for study participants are conducted in accordance with approved protocols. These activities include, but are not limited to patient ...screening, eligibility determination, registration and other protocol and subject milestones. The CRC will have direct patient contact and will be responsible for managing a multitude of clinical trials. The CRC will be assigned to a specific disease team(s) upon hire based on the candidate’s background.

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Connections working at Yale University Cancer Center Clinical Trials Office