Clinical Research Coordinator

Be You.

The Department of Anesthesiology at Duke University is seeking a highly motivated Clinical Research Coordinator to support and coordinate clinical research studies conducted by Principal Investigators within the department. This is an exciting opportunity to contribute to innovative clinical research while working with multidisciplinary teams dedicated to improving patient care and advancing scientific discovery.

In this role, you will participate in and lead day-to-day clinical research operations, including participant recruitment and retention, informed consent, regulatory submissions, study documentation, data collection and management, specimen processing, and study coordination. You will work closely with investigators, sponsors, regulatory bodies, and research participants to ensure studies are conducted in compliance with institutional, regulatory, and ethical standards. The ideal candidate will demonstrate strong organizational skills, attention to detail, and the ability to independently manage complex research activities while contributing to a collaborative research environment.

Minimum Requirements

• Associate's degree required.
• Minimum of two years of relevant clinical research experience.
• Completion of the DOCR North Carolina State-Approved Clinical Research Apprenticeship Program may substitute for one year of required experience.
• Experience coordinating clinical research studies and working with research participants.
• Knowledge of clinical research regulations, Good Clinical Practice (GCP), human subject protections, and Institutional Review Board (IRB) processes.
• Experience maintaining study documentation and preparing regulatory submissions.
• Ability to manage investigational products, study specimens, and study-related records as required by protocol.
• Strong verbal and written communication skills.
• Excellent organizational skills, attention to detail, and ability to manage multiple priorities simultaneously.
• Demonstrated ability to work independently and collaboratively in a multidisciplinary clinical research environment.
• Proficiency with Microsoft Office applications and web-based systems.

Preferred Qualifications

• Experience with Duke clinical research systems, including OnCore, eReg, iRIS, Maestro Care, or similar research management platforms.
• Experience supporting greater-than-minimal-risk, procedural, interventional, or federally regulated clinical studies.
• Familiarity with data analysis tools and reporting software.
• Experience supporting monitoring visits, audits, and sponsor interactions.
• Experience developing standard operating procedures (SOPs) and research workflows.

Key Responsibilities

Research Operations

• Coordinate and conduct study visits in accordance with approved protocols.
• Recruit, screen, enroll, and retain research participants.
• Maintain regulatory and study documentation.
• Prepare submissions and ongoing documentation for sponsors, regulatory agencies, and oversight committees.
• Manage investigational products and study specimens according to protocol requirements.
• Support monitoring visits, audits, and inspections.

Safety and Regulatory Compliance

• Conduct and document informed consent activities.
• Prepare and submit IRB applications, amendments, continuing reviews, and reportable events.
• Monitor and document adverse events and protocol deviations.
• Ensure compliance with institutional, sponsor, federal, and ethical requirements.

Data Management

• Collect, enter, validate, and manage research data.
• Ensure data accuracy, completeness, quality, and security.
• Develop reports, summaries, and visualizations to communicate study progress and outcomes.
• Support data sharing and repository submissions when applicable.

Professional Development and Leadership

• Contribute to team training and mentorship activities.
• Participate in departmental meetings, research initiatives, and professional development opportunities.
• Collaborate effectively with investigators, research staff, sponsors, and institutional partners.

Work Arrangement

• Onsite. The work is performed on-site at Duke University in Durham, North Carolina.

Why Duke?

At Duke, you will join a collaborative research community committed to excellence, innovation, and improving human health. You will have the opportunity to work alongside world-class investigators while developing your research career within one of the nation's leading academic medical centers.

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

Be Bold. Be Collaborative. Be Impactful. Choose Duke.