Clinical Research Coordinator

Be You. Be Bold. Choose Duke.

Clinical Research Coordinator

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 play a critical role in advancing clinical research that improves patient care, drives scientific discovery, and transforms health outcomes.

You'll work alongside investigators, research participants, sponsors, and multidisciplinary teams to coordinate studies with excellence, ensure regulatory compliance, and help bring innovative treatments and discoveries closer to the patients who need them most. Your expertise in study operations, participant engagement, and research compliance will contribute directly to Duke's mission of advancing health together.

Be Bold.

Clinical research is powered by people who bring precision, curiosity, and compassion to every interaction. In this role, you'll help manage complex research activities while serving as a trusted resource for participants, study teams, and research partners.

What You'll Do:

Research Operations & Participant Management

• Independently screen and recruit participants for a variety of research studies.
• Schedule study visits and coordinate participant activities throughout the research lifecycle.
• Conduct and document informed consent processes in accordance with study protocols and regulatory requirements.
• Employ retention and engagement strategies that support positive participant experiences and study success.
• Collect, process, ship, track, and maintain inventories of research specimens.
• Maintain participant and study-level documentation, including enrollment logs, regulatory binders, and required research records.
• Assist participants with study-related needs while ensuring adherence to research protocols.
• Support monitoring visits, audits, and regulatory reviews, including implementation of corrective actions as needed.

Investigational Product & Regulatory Compliance

• Assist with the management, tracking, storage, dispensing, and documentation of investigational products (IP).
• Coordinate with investigational pharmacies and study teams to maintain protocol compliance.
• Monitor and document investigational product accountability at both participant and protocol levels.
• Develop and maintain IRB submissions, including protocols, consent forms, continuing reviews, and regulatory documents.
• Prepare adverse event documentation and assist with required sponsor and regulatory reporting activities.
• Ensure study activities comply with institutional, sponsor, federal, and regulatory requirements.

Ethics & Participant Protection

• Clearly communicate the distinction between clinical care and research participation.
• Promote ethical research practices and participant-centered communication.
• Support research involving diverse and vulnerable populations while ensuring appropriate safeguards are maintained.
• Assist in the development of Conflict of Interest (COI), Data Safety Monitoring Plans (DSMPs), and Research Data Security Plans (RDSPs).
• Support external monitoring boards and safety oversight activities.
• Communicate study risks, benefits, and participant protections effectively.

Study Management & Quality Oversight

• Evaluate recruitment feasibility and support development of enrollment and retention strategies.
• Maintain compliance with institutional requirements, sponsor expectations, and federal reporting obligations.
• Support protocol implementation through development of workflows, process maps, training materials, standard operating procedures, and case report forms.
• Maintain Delegation of Authority logs and assist with study-specific training for research personnel.
• Participate in site initiation, monitoring, and closeout activities.
• Lead or support study closeout, document retention, and regulatory file management activities.

Communication & Collaboration

• Serve as a primary liaison with sponsors, vendors, subcontractors, and other external partners.
• Participate actively in study team meetings and operational planning discussions.
• Respond to routine protocol inquiries and facilitate appropriate resolution of study-related issues.
• Coordinate with investigators, research staff, and institutional partners to support successful study implementation.
• Communicate professionally and effectively with participants, colleagues, and external stakeholders.

Leadership & Professional Development

• Foster a collaborative and supportive team environment.
• Identify opportunities for process improvement and operational efficiency.
• Mentor and support colleagues through sharing knowledge and best practices.
• Maintain required Duke and study-specific certifications and training.
• Promote cultural awareness, diversity, and inclusion in research design and participant engagement.
• Stay current on evolving clinical research regulations, best practices, and institutional policies.

What You'll Bring:

Required Qualifications

• Education and experience consistent with Duke Clinical Research Coordinator requirements.
• Experience coordinating clinical research studies and working with human subjects research protocols.
• Knowledge of research regulations, informed consent processes, and participant protections.
• Ability to manage multiple projects, priorities, and deadlines in a fast-paced research environment.
• Strong organizational, analytical, and problem-solving skills.

Preferred Qualifications

• Experience working with investigational products, sponsor-funded studies, and regulatory submissions.
• Familiarity with IRB submissions, adverse event reporting, and study monitoring activities.
• Experience collaborating with sponsors, vendors, and multidisciplinary study teams.
• Knowledge of clinical research systems, databases, and regulatory documentation practices.

Preferred Skills

• Excellent verbal and written communication skills.
• Strong attention to detail and documentation accuracy.
• Ability to work independently while maintaining high standards of quality and compliance.
• Commitment to participant-centered research and ethical conduct.
• Demonstrated leadership, collaboration, and continuous improvement mindset.

Why Duke?

• Join one of the nation's leading academic research institutions.
• Contribute to groundbreaking clinical research that advances patient care and scientific discovery.
• Collaborate with world-renowned investigators, clinicians, and research professionals.
• Access opportunities for career growth, professional development, and ongoing learning.
• Work in a culture that values innovation, inclusion, integrity, and excellence.
• Help improve the health and well-being of patients and communities through research.

Choose Duke.

At Duke, our greatest discoveries begin with people. We are committed to creating a culture of collaboration, creativity, and belonging where diverse perspectives fuel innovation and meaningful impact. Every member of our community plays a role in advancing our mission and improving lives.