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 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home 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, you’ll be an essential part of a collaborative research environment that supports innovative clinical studies while ensuring ethical, safe, and compassionate care for diverse populations. Your expertise helps advance critical discoveries that improve health outcomes locally and globally.

Be Bold.

Bring your drive, curiosity, and dedication to a team pushing the boundaries of clinical research at Duke. In this role, you’ll take ownership of complex study operations, support investigators, and help ensure that every study is conducted with excellence, integrity, and purpose.

What You’ll Do

Research Operations

• Identify when MTAs, CDAs, DUAs, DTAs, and similar agreements are needed and communicate with the appropriate teams.
• Support or prepare FDA regulatory submissions in partnership with ORAQ, including development, submission, maintenance, and follow‑up on review or hold issues.
• Apply knowledge of institutional and regulatory processes in protocol submissions, documentation, and SOP development.
• Manage investigational product (IP), including receipt, storage, tracking, and participant provision.
• Serve as liaison with sponsors, IDS, and external collaborators.
• Follow randomization and blinding/unblinding procedures.
• Support international study management and documentation as needed.
• Prepare for and support monitoring visits and audits, addressing findings promptly.
• Maintain all participant and study-level documentation for greater‑than‑minimal risk or complex studies.
• Develop and implement recruitment and retention strategies; escalate issues as needed.
• Screen participants for high‑complexity studies.
• Develop SOPs and manage human specimen collection, processing, shipment, and inventory.
• Conduct protocol-compliant study visits and contribute to effective team meetings, occasionally leading multidisciplinary discussions.

Safety & Ethics

• Identify AEs, determine reportability, and assess relatedness with the PI.
• Conduct and document informed consent for greater‑than‑minimal risk studies, including those requiring Maestro Care orders.
• Develop consent forms and plans; submit IRB documentation through iRIS and respond to reviewer feedback.
• Prepare regulatory and safety submissions for sponsors and agencies.
• Ensure ethical conduct with special attention to vulnerable populations.
• Communicate clearly about the differences between clinical care and research participation.

Data

• Enter and collect data; develop SOPs and tools to support data workflows.
• Train and oversee staff performing data entry or collection.
• Ensure data accuracy and escalate quality concerns.
• Develop QA tools and support adherence to security standards for electronic and physical data.
• Develop or review data lifecycle plans and map workflow from capture to analysis and sharing.
• Apply open science practices and FAIR principles.
• Prepare datasets for repository submission and assist with data‑sharing plans.
• Prepare tables, visualizations, lay summaries, and progress reports for PIs and stakeholders.
• Support qualitative or statistical analysis using tools such as SAS, R, SPSS, NVivo, or Atlas.ti.

Scientific Concepts

• Assist with funding proposal development.
• Conduct literature searches and reviews.
• Contribute to protocol development, using PI scientific proposals as a framework.
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