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. At Duke, we celebrate individuality and the unique perspectives that each member of our community brings. As a Clinical Research Coordinator in the Ophthalmology Clinical Research Unit (CRU), you will play a key role in advancing innovative vision research while collaborating with physicians, scientists, study participants, sponsors, and multidisciplinary healthcare teams. This position offers the opportunity to serve as a primary study coordinator supporting a diverse portfolio of clinical research studies. If you are passionate about patient-centered research, regulatory excellence, and improving outcomes through scientific discovery, we encourage you to bring your talents to Duke. --------------------------------------------------------------- Be Bold. As a valued member of our research team, you will independently coordinate and manage clinical research studies from study start-up through closeout while ensuring compliance with institutional, regulatory, and sponsor requirements. What You'll Do Study Coordination & Participant Management

• Serve as the primary coordinator for ophthalmology clinical research studies.
• Screen, recruit, consent, and retain study participants according to protocol requirements.
• Schedule and coordinate research visits, procedures, testing, and follow-up activities.
• Conduct and document study visits, interviews, and participant interactions.
• Manage participant reimbursement and study-related communications.
• Implement strategies to maintain participant recruitment and retention goals.
• Collaborate closely with investigators, clinical staff, sponsors, and research partners.

Regulatory & Compliance Management

• Prepare and maintain regulatory documentation throughout the study lifecycle.
• Develop and submit IRB applications, amendments, continuing reviews, and reportable events through iRIS.
• Coordinate FDA submissions and regulatory communications in partnership with institutional offices and investigators.
• Recognize when agreements such as MTAs, CDAs, DUAs, and DTAs are required and facilitate appropriate reviews.
• Support study monitoring visits, audits, inspections, and sponsor reviews.
• Address findings and implement corrective actions when necessary.
• Ensure studies are conducted in compliance with Good Clinical Practice (GCP), institutional policies, and applicable regulations.

Investigational Product & Study Operations

• Manage all aspects of investigational product accountability, including receipt, storage, inventory, tracking, and documentation.
• Coordinate randomization and blinding/unblinding activities according to protocol requirements.
• Maintain study-level documentation and essential regulatory files.
• Support international research activities and associated study documentation when applicable.
• Assist with study feasibility assessments and operational planning.
• Prepare studies for closeout and long-term records management.

Data Management & Quality Assurance

• Collect, enter, review, and maintain research data with a high level of accuracy and integrity.
• Monitor data quality and identify trends requiring escalation or corrective action.
• Develop or support data collection tools and quality assurance processes.
• Ensure compliance with data security, confidentiality, and data sharing requirements.
• Utilize research technologies, electronic data capture systems, EHR platforms, OnCore, and eREG systems to support study operations.
• Create reports, summaries, data visualizations, and study progress updates for investigators and stakeholders.

Scientific Contributions

• Conduct literature reviews and contribute to protocol development.
• Assist with grant applications and funding proposals.
• Support preparation of scientific presentations, abstracts, manuscripts, and publications.
• Contribute to dissemination of research findings through posters, presentations, and publications.

Leadership & Collaboration

• Serve as a resource for research staff and may train or mentor team members.
• Participate in multidisciplinary meetings and sponsor interactions.
• Contribute to process improvement initiatives and development of standard operating procedures.
• Maintain professional certifications and stay current with evolving clinical research practices.
• Demonstrate organizational awareness, adaptability, and strong collaborative skills across Duke's research enterprise.
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Clinical Responsibilities

• Perform ophthalmic research-related assessments and coordinate protocol-specific clinical procedures.
• Support participant care activities associated with ophthalmology research protocols.
• Collaborate with ophthalmologists, research staff, and study sponsors to ensure successful protocol execution.
• Maintain participant safety and adherence to study requirements.
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Type of Research This position supports a diverse portfolio of clinical research studies within the Ophthalmology Clinical Research Unit, serving as the primary coordinator for assigned protocols. Studies may include observational, interventional, procedural, device, pharmaceutical, and investigator-initiated research. --------------------------------------------------------------- What We're Looking For Required Qualifications

• Experience coordinating clinical research studies in a healthcare, academic, or research environment.
• Knowledge of clinical research regulations, Good Clinical Practice (GCP), and human subject protections.
• Strong organizational, communication, and project management skills.
• Experience working with research databases, electronic health records, and study management systems.

Preferred Qualifications

• Certified Ophthalmic Assistant (COA) or Certified Ophthalmic Technician (COT) certification strongly preferred/required.
• Experience supporting ophthalmology clinical research studies.
• Familiarity with FDA-regulated studies, investigational products, and sponsor interactions.
• Experience using OnCore, eREG, iRIS, and related clinical research systems.
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Choose Duke. At Duke, you'll join a nationally recognized academic medical center and research enterprise dedicated to transforming health through discovery, innovation, and collaboration. You'll work alongside world-class clinicians, researchers, and educators while helping advance treatments and improve the lives of patients affected by vision-related conditions. Duke offers:

• A collaborative and inclusive work environment.
• Opportunities for professional growth and career development.
• Access to cutting-edge research and innovative technologies.
• Comprehensive benefits and wellness programs.
• The opportunity to make a meaningful impact on patient care and scientific advancement.

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: View email address on click.appcast.io; phone: View phone number on click.appcast.io).