Clinical Research Coordinator

Duke Clinical Research Institute
United States, North Carolina, Durham
Nov 11, 2026
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 Foster Center for Ocular Immunology and Inflammation Be You. At Duke, we celebrate individuality and the unique perspectives each team member brings to advancing human health. As a Clinical Research Coordinator III with the Foster Center for Ocular Immunology and Inflammation, you will play a critical role in managing complex ophthalmology clinical research studies that improve patient outcomes and advance scientific discovery. You will join a collaborative team of physicians, researchers, research coordinators, sponsors, and regulatory specialists dedicated to developing innovative treatments for ocular inflammatory and immunologic diseases. Your expertise, initiative, and commitment to excellence will help shape the future of vision research. Be Bold. As a seasoned clinical research professional, you will independently coordinate and manage clinical trials and research studies from startup through closeout while ensuring regulatory compliance, participant safety, data integrity, and operational excellence. What You'll Do Clinical Trial Operations & Regulatory Management Coordinate and manage complex clinical research studies, including procedural and interventional protocols. Identify when research agreements such as MTAs, CDAs, DUAs, and DTAs are required and engage appropriate stakeholders. Prepare, submit, and maintain regulatory documentation and FDA submissions in collaboration with ORAQ and Principal Investigators. Support responses to FDA reviews, requests, and potential clinical holds. Develop, maintain, and organize essential study documentation and regulatory binders. Prepare studies for monitoring visits, audits, inspections, and closeout activities. Address findings and implement corrective actions as needed. Assist with development and maintenance of standard operating procedures (SOPs). Participant Recruitment, Screening & Retention Develop and implement participant recruitment and retention strategies. Screen and evaluate potential research participants for study eligibility. Conduct study visits in accordance with protocol requirements. Monitor enrollment and retention metrics and proactively identify and address barriers. Coordinate participant scheduling, follow-up activities, and ongoing engagement. Informed Consent & Research Ethics Conduct and document informed consent for minimal-risk and greater-than-minimal-risk studies. Develop consent processes and participant education materials. Identify, document, evaluate, and report adverse events and safety concerns. Collaborate with investigators to determine event relatedness and reporting requirements. Prepare and submit documentation for IRB review and regulatory reporting. Investigational Product Management Oversee all aspects of investigational product management. Coordinate receipt, storage, accountability, tracking, dispensing, and reconciliation activities. Serve as the primary liaison with sponsors, Investigational Drug Services (IDS), and other research partners. Support protocol-specific randomization and blinding requirements. Data Management & Research Quality Collect, enter, review, and maintain high-quality research data. Develop data collection tools and quality assurance processes. Monitor data accuracy, trends, and protocol compliance. Maintain secure handling of confidential participant information and study records. Support data sharing initiatives and application of FAIR data principles. Prepare reports, dashboards, visualizations, and study summaries for investigators and stakeholders. Scientific & Scholarly Contributions Conduct literature reviews and support protocol development. Assist with grant applications and funding proposals. Contribute to scientific presentations, abstracts, manuscripts, and publications. Support dissemination of research findings through presentations and scholarly activities. Study & Site Management Utilize OnCore, eREG, EHR systems, and other clinical research management tools. Coordinate sponsor interactions, study feasibility assessments, and site visits. Track milestones, participant activities, timelines, and study deliverables. Ensure study compliance with Duke policies, federal regulations, GCP guidelines, and sponsor requirements. Coordinate study closeout and records retention activities. Leadership & Professional Development Serve as a resource for research staff and study team members. Train, mentor, and oversee research personnel as appropriate. Participate in institutional committees, workgroups, and professional development activities. Promote continuous process improvement and operational excellence. Foster a collaborative and inclusive research environment. Clinical Portfolio Focus This position supports the Foster Center for Ocular Immunology and Inflammation and its portfolio of clinical research studies focused on ocular inflammatory and immune-mediated diseases. Special Skills & Preferred Experience Certified Ophthalmic Professional credential required or strongly preferred. Demonstrated ophthalmology research experience. Knowledge of ocular immunology and inflammatory eye disease research. Experience managing clinical research studies involving investigational products and regulatory submissions. Strong understanding of FDA regulations, ICH-GCP guidelines, and human subjects research protections. Experience using clinical research systems such as OnCore, eREG, iRIS, and Epic/Maestro Care preferred. Exceptional organizational, communication, and stakeholder management skills. Choose Duke. At Duke University and Duke Health, you'll find a culture of collaboration, innovation, and purpose. You'll work alongside world-class clinicians and researchers while contributing to groundbreaking discoveries that improve lives around the world. Duke offers competitive compensation, comprehensive benefits, professional development opportunities, and a commitment to fostering an inclusive environment where every team member can thrive. Ready to Make a Difference? Apply today and help advance innovative ophthalmology research while improving vision and quality of life for patients worldwide. Be You. Be Bold. Choose Duke. 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: 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: DAAS@duke.edu; phone: 919-668-1267).