Senior Clinical Research Coordinator - Regulatory/Ops Lead

Duke Clinical Research Institute; Durham (NC); On-site; USD 71,000 - 113,000; Full time

Job summary

The Children's Clinical Research Unit within the Department of Pediatrics at Duke University is seeking a Senior Clinical Research Coordinator to provide leadership across complex clinical trials, from startup through closeout. You will serve as a trusted regulatory resource and oversee data integrity, participant recruitment, and study documentation.

This onsite role in Durham, NC requires guiding multiple study teams, training staff, and ensuring compliance with IRB submissions, consent

Qualifications

• Requires an associate's degree and six years of research experience.
• A bachelor's degree may substitute 2 years of required experience.

Responsibilities

• Serves as a senior research operations and regulatory expert across multiple study teams.
• Leads preparation for monitoring and audits and mentors staff.
• Ensures compliance with adverse event reporting and informed consent processes.
• Oversees regulatory submissions, study documentation, and cross-site coordination.

Skills

Leadership

Regulatory compliance

Study operations

Data quality

Participant recruitment

Staff development

Education

Associate's degree

Bachelor's degree substitution

Tools

OnCore

iRIS

eREG

CQMP

MaestroCare

Job description

The Children's Clinical Research Unit within the Department of Pediatrics at Duke University is seeking a Senior Clinical Research Coordinator to provide leadership across complex clinical trials, from startup through closeout. You will serve as a trusted regulatory resource and oversee data integrity, participant recruitment, and study documentation.

This onsite role in Durham, NC requires guiding multiple study teams, training staff, and ensuring compliance with IRB submissions, consent