Clinical Research Coordinator

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. Be Bold. Choose Duke.

Clinical Research Coordinator II

Reports to: Jessica Shier, Research Program Leader, Sr.

Be You.

At Duke, we celebrate individuality and the unique perspectives each team member brings to advancing world-class research. As a Clinical Research Coordinator II , you will play a vital role within one of our pulmonary research clusters, helping to connect innovative research with the patients and communities we serve. You will join a collaborative team dedicated to improving outcomes for individuals with pulmonary and critical illness through groundbreaking clinical research.

Be Bold.

Join a dynamic research environment where you will coordinate complex clinical studies, engage participants throughout their research journey, and contribute to discoveries that have the potential to transform patient care.

What You'll Do

Clinical Research Operations

• Coordinate and manage complex clinical research studies, including procedural and interventional protocols.
• Recruit, screen, consent, enroll, and retain research participants while ensuring compliance with protocol requirements.
• Manage participant scheduling, study visits, randomization activities, and protocol adherence.
• Maintain participant-level and study-level documentation for complex clinical research studies.
• Oversee investigational product (IP) receipt, storage, accountability, tracking, and dispensing activities.
• Prepare studies for monitoring visits, audits, site visits, and closeout activities, addressing findings and implementing corrective actions as needed.
• Serve as a primary liaison between sponsors, CROs, Investigational Drug Services (IDS), principal investigators, and other study stakeholders.

Regulatory & Compliance

• Prepare and submit regulatory documents to the IRB through iRIS.
• Support protocol submissions, study amendments, continuing reviews, and safety reporting requirements.
• Ensure research activities comply with institutional policies, Good Clinical Practice (GCP), FDA regulations, and human subject protection standards.
• Recognize when research agreements (MTAs, CDAs, DUAs, DTAs, etc.) are required and coordinate with appropriate parties.
• Identify adverse events (AEs), support evaluation of reportability, and collaborate with investigators regarding event assessment.

Data & Research Administration

• Collect, enter, verify, and maintain research data to ensure accuracy, completeness, and integrity.
• Utilize systems including OnCore, eREG, REDCap, and Epic/Maestro Care to manage research protocols and participant activities.
• Monitor data quality trends and assist with quality assurance activities.
• Develop reports, study summaries, visualizations, and progress updates for investigators and research teams.
• Support data sharing, repository submission, and FAIR data practices when appropriate.

Scientific Contributions

• Assist with grant proposals, research presentations, posters, publications, and dissemination of research findings.
• Contribute to scientific publications and presentations as an author or co-author.
• Participate in feasibility assessments for new studies and provide operational recommendations.

Leadership & Collaboration

• Support onboarding and training of research staff and study team members.
• Participate in multidisciplinary meetings and collaborate across clinical, research, and administrative teams.
• Maintain current knowledge of Duke research processes, regulatory requirements, and clinical research best practices.
• Demonstrate adaptability, resilience, and a commitment to continuous learning.

Minimum Qualifications

Education/Training

• Completion of an Associate's degree.

Experience

• Work requires a minimum of two years of relevant research experience.
• Completion of the DOCR North Carolina State Approved Clinical Research Apprenticeship Program may substitute for one year of required experience.

Skills

• Ability to effectively use computing software and web-based applications, including Microsoft Office products and internet browsers.

Preferred Qualifications

• Bachelor's degree in Health Science, Biological Science, Public Health, Nursing, or a related field.
• Experience coordinating clinical research studies.
• Experience with IRB submissions, regulatory compliance, and sponsor communications.
• Familiarity with OnCore, Epic/Maestro Care, REDCap, eREG, and electronic data capture systems.
• Experience processing human biospecimens and maintaining laboratory documentation.
• Strong organizational skills and attention to detail.
• Ability to manage multiple studies and priorities simultaneously.
• Excellent written and verbal communication skills.

Desired Competencies

• Knowledge of Good Clinical Practice (GCP), FDA regulations, and human subject protections.
• Ability to work independently while collaborating effectively in a multidisciplinary academic environment.
• Strong critical thinking and problem-solving skills.
• Commitment to advancing innovative research that improves outcomes for patients with pulmonary and critical illness.
• Ability to navigate complex research environments and build productive working relationships with diverse stakeholders.

Choose Duke.

At Duke, you will have the opportunity to contribute to leading-edge clinical research while working alongside renowned investigators, clinicians, and research professionals. Your work will directly support discoveries that improve patient care and advance the future of pulmonary and critical care medicine. Here, your ideas, expertise, and passion will help shape meaningful change for patients and communities around the world.

Ready to Make a Difference?

Apply now and help us build a stronger, smarter, and more connected future.

Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $61,026.00 to USD $101,959.00. 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:

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: [click to reveal email address] View email address on us.fitly.work ; phone: [click to reveal phone number]View phone number on us.fitly.work).