Y

Yale University

Research university in New Haven, CT

Clinical Research Coordinator 2

Full-Time
$65k - $101k/yr
Junior, Mid
Bachelor's
New Haven, CT, USA
HybridHybrid work model; required on-site schedule is not specified.

About the job

Requirements
  • Bachelor’s degree in a health-related discipline or another related field, or an equivalent combination of education and experience.
  • At least two years of clinical research experience, or an equivalent combination of education and experience.
  • At least one year of experience in clinical trials coordination.
  • Knowledge of Good Clinical Practices and federal regulations.
  • 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 Health Insurance Portability and Accountability Act requirements.
  • Ability to manage multiple studies independently and handle multiple tasks in a fast-paced environment with strong attention to detail.
  • Ability to handle confidential information and exercise professional judgment.
Responsibilities
  • Provide research services and direct patient contact for patients participating in clinical trials.
  • Oversee, plan, track, and ensure clinical activities for study participants are conducted according to approved protocols.
  • Serve as the primary oversight specialist for clinical and operational processes on 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, International Council for Harmonisation Good Clinical Practice, federal regulations, and institutional processes.
  • Ensure adherence to study protocols; oversee accurate documentation, participant recruitment, and compliance with International Council for Harmonisation Good Clinical Practice, federal, institutional, and sponsor requirements.
  • Identify protocol noncompliance and deviations, and report and advise on them to the 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.
  • Collaborate with Investigators and Research Managers to prepare and execute corrective and preventive action plans and ensure their implementation and adherence.
  • Collaborate with the Quality Education Unit on the design of coordinator 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 for Clinical Research Coordinator I development.
  • Monitor, interpret, and communicate federal and state regulations and local policies relating to new guidance, updates, or policies.
Desired Qualifications
  • Knowledge of clinical trial management systems and experience with electronic medical records.
  • Oncology experience.
  • Bachelor’s degree in a scientific, health-related, or business administration field.
  • Advanced research training.
  • Demonstrated experience in clinical trials coordination.
  • Certification from the Association of Clinical Research Professionals, Society of Clinical Research Associates, or an equivalent organization.

About the company

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

N/A

Company Stage

N/A

Total Funding

N/A

Headquarters

N/A

Founded

N/A

Get referred to Yale University

See people who can refer or advise you