CLINICAL RESEARCH COORDINATOR

Be You.

The Duke Office of Clinical Research is looking for a Clinical Research Coordinator to join our team. You will lead or participate in day-to-day operations across clinical research studies-screening and consenting participants, conducting protocol-specific visits and tests, and ensuring meticulous documentation and data quality. This role is a chance to make a direct impact on participant safety and study integrity while partnering with investigators, clinics, and core services across Duke.

Minimum Requirements:

• Completion of a Bachelor's degree. Completion of an Associate's degree plus a minimum of two years relevant experience (e.g., research, clinical, interaction with study population, program coordination)

Essential Task / Responsibilities:

Clinical Research Operations

• Screen, schedule, consent participants, and collect adverse event information across multiple studies.
• Maintain subject-level documentation, including consent in the electronic medical record.
• Prepare documents, equipment, and supplies for research visits; conduct and document visits and protocol-specific testing/interviews per SOPs.
• Implement strategies to maintain recruitment and retention; evaluate processes and assist participants with individual needs.
• Train junior staff in operational tasks as needed.

Specimen & Investigational Product Management

• Collect, prepare, process, ship, and maintain inventory of research specimens; train others and improve handling systems.
• Manage Investigational Products (IP): arrival, storage, handling, requisitions, inventory, accountability, reconciliation, and destruction.
• Ensure compliance with IP handling systems for sponsored and investigator-initiated protocols; track protocol- and subject-level IP compliance.

Regulatory & Documentation

• Prepare for monitoring and audit visits; assist with addressing findings.
• Develop or provide input for IRB documents (consent forms, protocols, continuing reviews) and maintain study-level documentation (regulatory binders, enrollment logs, patient registration).
• Coordinate with Duke core services (IDS, Biobank) and recognize when agreements (e.g., MTAs, INDs) are required.

Ethical & Participant Safety

• Maintain familiarity with ethical research conduct and safeguards for vulnerable populations; train junior staff on these principles.
• Assist in designing studies with appropriate safety measures; develop or support safety/security documents (e.g., Data Safety Monitoring Plans).
• Communicate risks and benefits of study participation clearly; recommend improvements to participant communications.

Data Management & Informatics

• Use and train others in EDC systems; accurately enter and score data; complete CRFs/eCRFs per protocol.
• Detect and resolve data issues; develop SOPs for data quality assurance; run queries, summaries, and reports.
• Ensure data security and provenance; map protocol data flow and address vulnerabilities.
• Recognize when data agreements or special regulatory requirements are needed and coordinate accordingly.

Scientific Concepts & Research Design

• Understand and train others in basic study design concepts; conduct literature reviews.
• Assist in developing proposals/protocols and identify shortcomings; coordinate with stakeholders for study design and implementation.

Leadership & Professionalism

• Mentor and train junior staff; assign and review work; provide constructive feedback and performance plans.
• Encourage team efficiency and career development; participate in committees, task forces, and scientific presentations/publications.
• Apply professional guidelines and code of ethics; identify and escalate potential risks to participants, studies, or institutions.

Study & Site Management

• Participate in sponsor-required training; coordinate operational plans for multiple studies.
• Develop protocol-specific systems and documents (process flows, training manuals, SOPs, CRFs).
• Support feasibility assessments, recruitment strategies, and financial routing for participant care expenses.

Preferred Qualifications:

• Phlebotomy experience

Other Requirements:

• Ability to travel across multiple Duke site locations in the Raleigh - Durham area.

This position is: Onsite. The work is performed on-site or at a designated assignment location.

Be Bold.

• Lead day-to-day study operations: screen, consent, schedule, and conduct protocol-specific visits/tests; maintain recruitment and retention strategies.
• Own data quality: use EDC systems; complete CRFs/eCRFs; investigate and resolve incomplete or inaccurate data; design QA processes and reports.
• Manage specimens and investigational products: collect/process/ship specimens; oversee IP arrival, storage, handling, accountability, reconciliation, and destruction.
• Drive regulatory excellence: prepare IRB submissions (consents, protocols, continuing reviews); maintain study-level documentation and support monitoring/audit readiness.
• Coordinate site management: participate in/lead site initiation, monitoring, and closeout; develop protocol-specific workflows; support feasibility, recruitment, and budgeting.

Choose Duke.

You will join a collaborative environment where clinical research advances patient care. In this role, you will interact with principal investigators, clinical departments, and core services, and you will be encouraged to pursue continuing education, network across teams, and contribute to scientific presentations and publications. If you are passionate about operational excellence, data integrity, and participant safety, this role is a great fit.