Y

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 - $101k

About the Job

Requirements

  • A bachelor's degree in a health-related discipline or another related field and two years of clinical research experience, or an equivalent combination of education or experience.
  • At least one year of experience in clinical trials coordination.
  • Knowledge of Good Clinical Practices and federal regulations.
  • Experience demonstrating the ability to work with minimal supervision in a team environment.
  • 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.
  • Professional judgment and ability to handle confidential information.
  • Advanced written and oral communication and interpersonal skills.
  • Ability to manage multiple tasks in a fast-paced environment with attention to detail.
  • Healthcare worker health requirements must be met before starting, including required vaccination or immunity documentation and screenings.

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 that clinical activities for study participants are conducted according to approved protocols, including patient screening, eligibility determination, registration, and other protocol milestones.
  • Serve as the primary oversight specialist for 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 protocol analysis and knowledge of clinical trials, operations, Good Clinical Practice, federal regulations, and institutional processes.
  • Ensure adherence to study protocols; oversee accurate documentation and participant recruitment; and ensure regulatory and protocol requirements are met in accordance with applicable guidelines and institutional and sponsor requirements.
  • Identify and report instances of noncompliance and protocol deviations, and advise appropriate parties.
  • Advise the Principal Investigator on protocol issues, signature status, clinical significance of laboratory reports and electrocardiograms, adverse events, and other required documents.
  • Analyze, document, and communicate 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 needing improvement or correction, and provide education or recommendations as needed.
  • Collaborate with Investigators and Research Managers to prepare and execute corrective and preventative action plans and ensure implementation and adherence.
  • Collaborate with the Quality Education Unit to contribute to the design of CRC trainings and continuing education.
  • Participate in interim monitoring visits, internal audits, and external audits or inspections.
  • Oversee work 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 in clinical trials coordination.
  • 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.

Company size
Not listed
Company stage
Not listed
Total funding
Not listed
Headquarters
Not listed
Founded
Not listed

Recently Posted Jobs

Explore more opportunities at Yale University

See more jobs