Clinical Research Coordinator, Sr

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

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School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

Be You.

The Children’s Clinical Research Unit within the Department of Pediatrics is seeking an experienced Clinical Research Coordinator, Senior, to join our team. In this role, you will provide leadership and operational expertise across multiple study teams, supporting complex clinical research studies from startup through closeout. You will serve as a trusted resource for regulatory compliance, study operations, data quality, participant recruitment and retention, as well as research staff development.

Minimum Requirements:

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

Preferred Qualifications:

• Previous experience with Duke Clinical Research systems including OnCore, iRIS, eREG, CQMP and maestrocare.

This position is Onsite. The work is performed on-site or at a designated assignment location.

Be Bold.

• Serves as a senior research operations and regulatory expert across multiple study teams, providing oversight, training, and strategic guidance on regulatory compliance, institutional policies, investigational product management, participant recruitment and retention, study documentation, specimen management, SOP development, and study conduct. Leads preparation for monitoring and audits, develops operational processes and tools, supports complex study visits and participant screening, facilitates cross-functional collaboration, and mentors staff to ensure high-quality research operations, effective communication, and achievement of study goals.
• Provides leadership, oversight, and training across multiple study teams to ensure compliance with adverse event reporting, informed consent processes, IRB submissions, and regulatory and safety reporting requirements. Serves as an expert resource for developing consent plans and documents, conducting and documenting informed consent for complex studies, navigating Duke research requirements, and ensuring regulatory submissions are accurate, timely, and compliant with institutional, sponsor, and regulatory expectations.
• Lead the department’s Clinical Quality Management Program reviews and support compliance surveillance activities, including patient research billing, Medicaid attestation submissions, Human Subjects Protection and Good Clinical Practice (GCP) training compliance, and maintenance of key Duke research systems (e.g., iRIS and OnCore).
• Provides strategic oversight and leadership across multiple study teams in sponsor and CRO communications, site visit management, protocol and participant tracking systems, study feasibility assessments, resource allocation, and financial oversight. Ensures research operations are conducted in compliance with institutional requirements, develops and implements operational and closeout plans, and oversees processes that support efficient study execution, participant management, and successful completion of research activities across multiple studies and sites.

Choose Duke.

At Duke, you will join one of the nation's leading academic research institutions where innovation, discovery, and collaboration drive meaningful improvements in patient care and health outcomes. You will help shape the future of clinical research while working alongside world-class investigators and research professionals.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $70,749.00 to USD $112,871.00. Duke University considers factors such as (but not limited to) scope and responsibilities of the position; candidate's work experience, education/training, and key skills; internal peer equity; as well as market and organizational considerations when extending an offer.

Your total compensation goesbeyond the dollars on your paycheck. Duke provides comprehensive and competitive medical and dental care programs, generous retirement benefits, and a wide array of family-friendly and cultural programs to eligible team members. Learn more at: https://hr.duke.edu/benefits/

Equal Opportunity Employer:

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.

Duke aspires to create a community built oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: [e-mail]; phone: [phone]).

Nearest Major Market: Durham
Nearest Secondary Market: Raleigh

Read more about Duke’s commitment to affirmative action and nondiscrimination at hr.duke.edu/eeo.