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Yale University

Research university in New Haven, CT

Clinical Research Coordinator 2

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeNew Haven, CT, USA$65k - $101kHybrid

About the Job

Requirements

  • Knowledge of clinical research terminology and regulatory requirements, including Good Clinical Practice, Food and Drug Administration regulations, and the Health Insurance Portability and Accountability Act.
  • Ability to manage multiple studies independently with minimal supervision in a team environment.
  • Bachelor's degree in a health-related discipline or another related field, or an equivalent combination of education and experience.
  • Two years of clinical research experience, including at least one year of clinical trials coordination experience.
  • Knowledge of Good Clinical Practices and federal regulations.
  • Ability to handle confidential information with professionalism and sound judgment.
  • Ability to manage multiple tasks in a fast-paced environment with attention to detail.
  • Meet healthcare-worker health requirements before starting, including required immunizations or immunity, tuberculosis screening, and annual flu vaccination, with COVID vaccination according to university policy.
  • Complete the required pre-employment background screening.

Responsibilities

  • Provide research services to patients participating in clinical trials, including direct patient contact and management of clinical and operational aspects of moderately to highly complex study protocols.
  • Oversee, plan, track, and ensure clinical activities for study participants are conducted in accordance with approved protocols, including patient screening, eligibility determination, registration, and other protocol milestones.
  • Serve as the primary oversight specialist on clinical and operational processes for moderately to highly complex protocols.
  • Manage, implement, and evaluate all aspects of clinical trial conduct, including study initiation, execution and maintenance, completion, and administration.
  • Contribute to study feasibility reviews and make recommendations based on analysis of protocols and knowledge of clinical trials, operations, Good Clinical Practice, federal regulations, and institutional processes.
  • Ensure study protocols are followed; oversee accurate documentation and participant recruitment; and ensure regulatory and protocol requirements are met according to applicable guidelines and institutional and sponsor requirements.
  • Identify and report instances of noncompliance and protocol deviations, and advise appropriate parties.
  • Advise the Principal Investigator by providing updates on protocol issues, signature status, and the clinical significance of laboratory reports, electrocardiograms, adverse events, and other required documents.
  • Analyze, document, and convey study data; collaborate with assigned staff to ensure report forms are accurate and completed on time.
  • Oversee tracking and reporting of adverse events, serious adverse events, protocol waivers, deviations, and violations.
  • Assess trial execution across the program, identify areas for improvement or correction, and provide education or recommendations as needed.
  • Collaborate with Investigators and Research Managers to prepare and execute corrective and preventive action plans, and ensure implementation and adherence.
  • Collaborate with the Quality Education Unit to contribute to the design of CRC training and continuing education.
  • Participate in interim monitoring visits, internal audits, and external audits or inspections.
  • Oversee the work of and advise on protocol management and recruitment to support CRC I development.
  • Monitor, interpret, and communicate federal and state regulations and local policies, including new guidance, updates, and policies.
  • Perform other duties as assigned.

Desired Qualifications

  • Knowledge of clinical trial management systems and experience with electronic medical records.
  • Oncology experience.
  • A bachelor's degree in a scientific, health-related, or business administration field; advanced research training is a plus.
  • Demonstrated experience coordinating clinical trials.
  • Certification from ACRP, SOCRA, or equivalent.

About the Company

Yale University

Research university in New Haven, CT

Yale University is a private research university in New Haven, Connecticut. It provides undergraduate, graduate, and professional education alongside research, scholarship, and public engagement.

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