Senior Clinical Research Coordinator: Operations & Compliance

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

Job summary

Duke University, through its Children’s Clinical Research Unit, seeks a Senior Clinical Research Coordinator to provide leadership across multiple study teams and support complex clinical trials from startup through closeout. You will ensure regulatory compliance, data quality, participant recruitment and retention, and staff development in a fast-paced academic environment.

The role requires an associate degree with six years of research experience (Bachelor's may substitute 2 years).

Qualifications

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

Responsibilities

• Lead regulatory compliance and research operations across multiple study teams.
• Lead preparation for monitoring and audits, and develop operational processes and tools.
• Provide training and mentorship on regulatory compliance for research staff.
• Oversee sponsor/CRO communications, site visits, and participant tracking across studies.

Skills

Regulatory compliance

Study operations

Data quality

Participant recruitment

Staff development

Education

Associate’s degree

Bachelor’s degree substitution for 2 years experience

Tools

OnCore

iRIS

eREG

CQMP

maestrocare

Job description

Duke University, through its Children’s Clinical Research Unit, seeks a Senior Clinical Research Coordinator to provide leadership across multiple study teams and support complex clinical trials from startup through closeout. You will ensure regulatory compliance, data quality, participant recruitment and retention, and staff development in a fast-paced academic environment.

The role requires an associate degree with six years of research experience (Bachelor's may substitute 2 years).