Clinical Research Coordinator II

At Duke Health, we celebrate individuality, curiosity, and the unique experiences that every team member brings to advancing discovery and improving patient care. As a Clinical Research Coordinator II, you will play a critical role in supporting innovative clinical research studies while partnering with investigators, research participants, sponsors, and interdisciplinary teams. Your expertise will help ensure studies are conducted ethically, efficiently, and in compliance with regulatory requirements.
You will join a collaborative research environment where your contributions directly support groundbreaking discoveries that improve health outcomes and impact lives locally and globally.

Be Bold.

As a Clinical Research Coordinator II, you'll independently manage and coordinate complex clinical research activities, ensuring excellence in participant safety, regulatory compliance, data integrity, and study operations.

What You'll Do:

Lead Research Operations

• Coordinate day-to-day activities for clinical research studies, including studies involving greater than minimal risk and complex interventions.
• Manage all aspects of investigational products, including receipt, storage, tracking, accountability, and participant dispensing.
• Serve as a primary liaison among sponsors, investigators, regulatory offices, research support services, and study teams.
• Prepare and maintain study documentation, regulatory files, standard operating procedures, and protocol submissions.
• Support study monitoring visits, audits, inspections, and closeout activities while addressing findings and implementing corrective actions.
• Coordinate participant recruitment, screening, enrollment, retention, and study visit activities.
• Collect, process, maintain, and ship research specimens according to protocol and regulatory requirements.

Advance Participant Safety and Research Ethics

• Conduct informed consent discussions and documentation for a wide range of research studies.
• Collaborate with investigators to identify, evaluate, document, and report adverse events and safety concerns.
• Prepare and submit Institutional Review Board (IRB) applications, amendments, continuing reviews, and safety reports.
• Ensure adherence to ethical principles, clinical research regulations, Duke policies, and participant protections.
• Educate participants regarding study procedures, risks, benefits, and distinctions between clinical care and research activities.

Support High-Quality Data Management

• Collect, enter, validate, and maintain research data using approved systems and procedures.
• Ensure data quality, completeness, accuracy, and regulatory compliance.
• Develop tools, workflows, and processes that improve data collection and quality assurance.
• Support data lifecycle management, data sharing activities, open science initiatives, and repository submissions.
• Create reports, dashboards, summaries, visualizations, and study metrics that support informed decision-making.
• Utilize research technologies and statistical tools to assist with quantitative and qualitative analyses.

Contribute to Scientific Discovery

• Conduct literature reviews and support development of research protocols and funding proposals.
• Assist with scientific presentations, posters, manuscripts, and dissemination of research findings.
• Apply knowledge of research methodology and study design to support successful study execution.
• Collaborate across disciplines to advance clinical and translational research initiatives.

Drive Study and Site Excellence

• Utilize clinical research systems, electronic health records, OnCore, eREG, and related platforms to manage study activities.
• Assess study feasibility and support operational planning efforts.
• Coordinate study resources, supplies, equipment, and participant scheduling.
• Ensure studies are conducted according to protocol, institutional requirements, sponsor expectations, and regulatory guidelines.
• Prepare studies for completion, closeout, and long-term document retention.

Grow as a Research Professional

• Provide guidance, training, and support to less experienced research staff as appropriate.
• Participate in professional development opportunities, research education programs, and institutional initiatives.
• Stay informed of emerging clinical research regulations, best practices, and industry developments.
• Foster collaborative relationships while demonstrating adaptability, accountability, and strong organizational awareness.

What You'll Bring:

Education

• Associate's degree required.

Experience

• 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.

Knowledge, Skills & Abilities

• Knowledge of clinical research principles, regulatory requirements, and Good Clinical Practice (GCP).
• Ability to manage multiple priorities in a dynamic research environment.
• Strong organization, communication, problem-solving, and collaboration skills.
• Experience with electronic research systems, data management platforms, and Microsoft Office applications.
• Ability to maintain confidentiality and uphold ethical research standards.

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: https://hr.duke.edu/benefits/