Senior Clinical Research Coordinator: Lead Study Ops

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

Job summary

Duke Careers is seeking a Senior Clinical Research Coordinator for on-site work with the Children’s Clinical Research Unit in the Department of Pediatrics. The role provides leadership across multiple study teams, ensuring regulatory compliance, patient safety, and high-quality study operations from startup through closeout.

The position emphasizes oversight of informed consent, study documentation, and cross-functional collaboration, with mentoring of staff to achieve study goals and regulatory

Qualifications

• Requires an associate’s degree and six years of research experience.
• A bachelor’s degree may substitute 2 years of required experience.
• Previous experience with Duke Clinical Research systems including OnCore, iRIS, eREG, CQMP and maestrocare.

Responsibilities

• Serve as senior research operations and regulatory expert across multiple study teams.
• Lead preparation for regulatory submissions and audits, ensure consent procedures are compliant.
• Provide oversight, training, and strategic guidance on regulatory compliance and study conduct.
• Oversee adverse event reporting, IRB submissions, and safety reporting requirements.

Skills

Regulatory compliance

Study operations

Data quality

Participant recruitment

Mentoring staff

Leadership

Education

Associate’s degree + 6 years research experience

Bachelor’s degree may substitute 2 years

Tools

OnCore

iRIS

eREG

CQMP

maestrocare

Job description

Duke Careers is seeking a Senior Clinical Research Coordinator for on-site work with the Children’s Clinical Research Unit in the Department of Pediatrics. The role provides leadership across multiple study teams, ensuring regulatory compliance, patient safety, and high-quality study operations from startup through closeout.

The position emphasizes oversight of informed consent, study documentation, and cross-functional collaboration, with mentoring of staff to achieve study goals and regulatory