Clinical Research Coordinator II, you will play a critical role in advancing innovative research focused on memory disorders and movement disorders. Working alongside physicians, neuroscientists, research participants, and multidisciplinary stakeholders, you will help drive complex clinical studies that improve patient outcomes and contribute to groundbreaking scientific discoveries.
You will join a collaborative and mission-driven environment where your expertise in clinical research operations, participant engagement, regulatory compliance, and data management will directly contribute to the advancement of neuroscience research.
What You'll Do:Clinical Research Operations- Coordinate and manage complex clinical research studies from activation through closeout.
- Maintain study documentation, regulatory files, standard operating procedures (SOPs), and participant records.
- Manage investigational products, including receipt, storage, accountability, tracking, and participant distribution.
- Serve as the primary liaison between study sponsors, Investigational Drug Services (IDS), regulatory offices, and research teams.
- Support study monitoring visits, audits, and inspections, ensuring timely resolution of findings and compliance requirements.
- Develop workflows, operational resources, and tools that enhance research efficiency and study execution.
Participant Recruitment & Retention- Screen, enroll, and retain research participants for procedural, interventional, and greater-than-minimal-risk studies.
- Conduct informed consent discussions and document participant consent in accordance with regulatory requirements.
- Develop and implement recruitment and retention strategies to support enrollment goals.
- Escalate recruitment barriers and proactively identify opportunities for process improvement.
Regulatory & Ethical Compliance- Prepare and submit Institutional Review Board (IRB) applications, amendments, continuing reviews, and safety reports.
- Partner with Principal Investigators to assess adverse events and determine reporting requirements.
- Ensure studies are conducted in compliance with federal regulations, institutional policies, Good Clinical Practice (GCP), and sponsor requirements.
- Maintain readiness for audits, inspections, and monitoring activities.
Data Management & Research Technology- Collect, enter, validate, and maintain high-quality research data across multiple platforms.
- Utilize electronic research systems such as OnCore, eReg, electronic data capture systems, and electronic health records.
- Apply FAIR data principles and open science practices to support data integrity and sharing.
- Monitor data quality trends and develop tools and processes that improve data accuracy and efficiency.
- Create study reports, dashboards, data visualizations, and summaries to communicate study progress and outcomes.
- Assist with statistical preparation and analysis using tools such as SAS, R, SPSS, Python, or MATLAB.
Scientific Contributions- Conduct literature reviews and support protocol development.
- Contribute to grant applications, scientific manuscripts, posters, and presentations.
- Collaborate with investigators to support dissemination of research findings.
- Serve as a contributing author on publications and presentations when appropriate.
Study & Site Management- Coordinate study start-up, site visits, monitoring activities, and study closeout.
- Assess study feasibility and support implementation planning.
- Track participant activities, financial milestones, timelines, and protocol requirements.
- Ensure adequate study supplies, equipment maintenance, and operational readiness.
- Develop and implement protocol-specific workflows, procedures, and process improvements.
Leadership & Professional Development- Mentor, train, and support research staff and study team members.
- Participate on institutional committees, workgroups, and professional research organizations.
- Stay current with evolving clinical research regulations, technologies, and best practices.
- Drive innovation and continuous improvement within the research program.
- Build effective partnerships across departments to achieve shared research goals.
What We're Looking ForRequired Qualifications- Associate's degree or higher.
- Minimum of two years of relevant clinical research experience.
- Completion of Duke Office of Clinical Research (DOCR) North Carolina State Approved Clinical Research Apprenticeship Program may substitute for one year of required experience.
Preferred Qualifications- Bachelor's degree in Psychology, Neuroscience, Computer Science, Cognitive Science, or a related field.
- Experience conducting Transcranial Magnetic Stimulation (TMS) procedures and data collection.
- Experience administering neuropsychological assessments in patient populations.
- Basic programming experience using Python, MATLAB, or similar platforms.
- Experience supporting interventional, behavioral, neurological, or cognitive research studies.
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/
