Clinical Research Coordinator 2

Yale University; New Haven (CT); On-site; USD 60,000 - 85,000; Full time

Job summary

Yale University seeks a Clinical Research Coordinator 2 to oversee clinical trial processes for complex protocols. This role involves managing study initiation to completion, ensuring compliance and participant recruitment. Ideal candidates are experienced in clinical trials with a health-related degree. Strong analytical and communication skills are essential for success.

Qualifications

• At least 2 years of clinical research experience.
• 1 year in clinical trial coordination.
• Knowledge of FDA regulations and GCP.

Responsibilities

• Manage all aspects of clinical trial conduct.
• Ensure adherence to study protocols and documentation.
• Collaborate on corrective action plans and ensure implementation.

Skills

Interpersonal skills

Analytical skills

Communication skills

Self-directed

Multitasking abilities

Education

Bachelor's degree in a health-related discipline

Tools

Clinical trial management systems

Microsoft Office

Job description

Position: Clinical Research Coordinator 2

Overview: Serves as the primary oversight specialist for clinical and operational processes on moderately to highly complex protocols. Manages all aspects of clinical trial conduct, including study initiation, execution, maintenance, completion, and administration.

1. Contributes to study feasibility reviews, analyzing protocols and providing recommendations based on clinical trial knowledge, operations, ICH/GCP, federal regulations, and institutional processes.
2. Ensures adherence to study protocols, maintains accurate documentation, manages participant recruitment, and complies with regulatory and protocol requirements per ICH/GCP, federal regulation, and sponsor standards.
3. Identifies and reports noncompliance and deviations, advising the appropriate parties.
4. Provides updates to Principal Investigators on protocol issues, signatures, lab reports, ECGs, adverse events, and other documentation.
5. Analyzes, documents, and communicates study data, ensuring timely and accurate report form completion.
6. Oversees tracking and reporting of adverse events, protocol waivers, deviations, and violations.
7. Assesses trial execution across programs, identifying areas for improvement and providing education or recommendations.
8. Collaborates on corrective and preventative action plans and ensures their implementation.
9. Contributes to CRC training and continuing education in collaboration with the Quality Education Unit.
10. Participates in interim monitoring visits, internal audits, and external inspections.
11. Advises on protocol management and recruitment strategies for CRC development.
12. Monitors and communicates updates on federal, state, and local regulations and policies.
13. Performs additional duties as assigned.

Required Skills/Abilities:

1. Professionalism, good judgment, and confidentiality handling; excellent interpersonal, oral, and written communication skills.
2. Self-directed with the ability to manage multiple studies independently, with flexibility.
3. Proven ability to multitask in a fast-paced environment.
4. Knowledge of FDA regulations, GCP guidelines, federal regulations, and institutional policies; strong computer skills, especially in Microsoft Office.
5. Analytical skills for moderate to complex assignments, guided by policies and guidelines, with moderate short-term impact.

Preferred Qualifications:

• Experience with clinical trial management systems and documenting in EMR.
• Oncology experience.
• Bachelor's degree in a health-related discipline or equivalent experience, with at least 2 years of clinical research experience and 1 year in clinical trial coordination.
• Knowledge of GCP and Federal Regulations.
• Ability to work independently within a team.

Work Schedule: Standard Monday-Friday, equal hours daily.