Senior Clinical Research Coordinator – Compliance & Study Management

Yale University; New Haven (CT); Hybrid; USD 65,000 - 101,000; Full time

Job summary

Yale Cancer Center is seeking a Research Coordinator to oversee clinical studies, manage start-up, recruitment, data collection, and regulatory submissions. You will ensure compliance with federal regulations and university policies while coordinating with sponsors and study teams.

The role requires strong communication, meticulous data handling, and a proactive approach to multi-project oversight in a fast-paced environment.

Qualifications

• Must manage clinical research projects adhering to protocols and regulatory requirements.
• Excellent verbal and written communication with diverse stakeholders.
• Strong organizational and time-management abilities for multiple projects.
• Experience with electronic data capture systems (EPIC) for trial management.
• Experience obtaining informed consent and documenting participant interactions.

Responsibilities

• Compare protocols and funding proposals with approved protocols for consistency.
• Document and ensure congruency between funding proposals and protocols.
• Assist with resolving inconsistencies between proposals and approvals.
• Act as liaison between Grants, investigators and managers to resolve issues.
• Attend meetings and raise issues identified during congruency reviews.
• Provide technical assistance to investigators and staff on regulatory matters.
• Support establishment and recording of protocol/grant congruency.

Skills

Clinical research management

Communication

Organizational skills

Informed consent processes

Regulatory liaison

Education

Bachelor’s degree in a relevant field

CCRP certification

FDA regulatory submissions experience

Experience with clinical trials

Tools

EPIC

REDCap

OnCore

Excel

Job description

Yale Cancer Center is seeking a Research Coordinator to oversee clinical studies, manage start-up, recruitment, data collection, and regulatory submissions. You will ensure compliance with federal regulations and university policies while coordinating with sponsors and study teams.

The role requires strong communication, meticulous data handling, and a proactive approach to multi-project oversight in a fast-paced environment.