Clinical Research Coordinator
Durham, NC, US, 27710
Be You. Be Bold. Choose Duke.
Clinical Research Coordinator - Neurosurgery Research
Be You.
At Duke, we celebrate individuality and the unique perspectives each team member brings to advancing medicine and improving lives. As a Clinical Research Coordinator within the Department of Neurosurgery, you will join a highly collaborative team dedicated to groundbreaking clinical research in both adult and pediatric populations. Our studies span Parkinson's disease, Alzheimer's disease, epilepsy, neuro-oncology, rare genetic disorders, traumatic brain and spinal injuries, chronic pain, and other complex neurological conditions.
You'll work alongside nationally recognized neurosurgeons, neuro-oncologists, scientist-clinicians, and PhD researchers who are passionate about discovery, innovation, and transforming patient care. If you thrive in a dynamic academic research environment and enjoy solving complex challenges while making a meaningful impact, Duke Neurosurgery offers an exceptional opportunity to grow your career.
Be Bold.
What You'll Do
As a senior clinical research professional, you will lead and support complex clinical trials throughout the study lifecycle while serving as a trusted resource for research teams, sponsors, and investigators.
Clinical Trial Operations
- Coordinate and manage complex clinical research studies, including drug, device, and procedural trials involving randomization, blinding, crossover designs, and investigational products.
- Maintain study documentation and regulatory records to ensure continuous compliance with institutional, sponsor, FDA, and international requirements.
- Prepare and support FDA submissions in partnership with regulatory experts and investigators.
- Manage investigational products, including receipt, storage, accountability, tracking, and participant dispensing.
- Serve as a primary liaison with sponsors, Contract Research Organizations (CROs), Investigational Drug Services (IDS), and internal stakeholders.
- Lead study monitoring, audit preparation, and corrective action activities.
- Support study startup, feasibility assessments, ongoing project management, and study closeout activities.
Participant Recruitment & Retention
- Develop and implement recruitment and retention strategies for complex clinical research studies.
- Screen, enroll, and monitor research participants while ensuring protocol adherence and participant safety.
- Identify barriers to enrollment and retention and implement solutions that enhance study performance.
- Conduct study visits in accordance with approved protocols and regulatory requirements.
- Participate in an established on-call research coverage rotation supporting critical care research activities.
Regulatory & Ethical Compliance
- Lead IRB submissions, amendments, continuing reviews, and safety reporting activities.
- Conduct informed consent discussions for studies involving greater-than-minimal risk and complex interventions.
- Collaborate with investigators to assess adverse events, determine reportability requirements, and maintain participant safety oversight.
- Develop and maintain regulatory tools, templates, standard operating procedures, and compliance resources.
Data & Research Excellence
- Ensure the integrity, quality, security, and completeness of research data.
- Utilize clinical research systems and electronic data capture tools to support protocol execution and reporting.
- Apply FAIR data principles and open science practices to facilitate data sharing and reproducibility.
- Support data management activities, including data cleaning, validation, quality assurance, database testing, and reporting.
- Create study progress reports, visualizations, summaries, and presentations for investigators and stakeholders.
- Assist with qualitative and quantitative data analyses using software such as SAS, R, SPSS, NVivo, or Atlas.ti.
Scientific Contribution
- Participate in protocol development, scientific literature reviews, and grant proposal preparation.
- Contribute to abstracts, presentations, posters, and peer-reviewed publications.
- Serve as an author or co-author on research dissemination activities when appropriate.
Leadership & Collaboration
- Mentor, train, and support research staff and study teams.
- Lead or contribute to multidisciplinary meetings involving investigators, sponsors, research partners, and institutional stakeholders.
- Share best practices and help develop operational resources that improve research performance.
- Serve on committees, workgroups, and professional development initiatives that advance Duke's research mission.
- Continuously expand expertise through professional development, certifications, and participation in research-focused educational opportunities.
What You'll Bring
Required Qualifications
- Bachelor's degree in a health-related, scientific, or research discipline, or an equivalent combination of education and experience.
- Experience coordinating clinical research studies with progressive responsibility.
- Demonstrated knowledge of clinical research regulations, Good Clinical Practice (GCP), FDA requirements, and human subject protections.
- Experience managing multiple priorities in a fast-paced research environment.
- Strong organizational, communication, problem-solving, and project management skills.
Preferred Qualifications
- Experience supporting neurology, neurosurgery, neuro-oncology, critical care, or device-based clinical research.
- Experience with investigational product management and complex interventional clinical trials.
- Knowledge of OnCore, eReg, Maestro Care/Epic, REDCap, or other clinical research systems.
- Professional certification such as CCRP, CCRC, ACRP, or SOCRA certification.
- Experience contributing to publications, grant submissions, or scientific presentations.
Key Competencies
- Clinical trial management
- Regulatory compliance
- Participant engagement and retention
- Data quality and data management
- Cross-functional collaboration
- Critical thinking and problem solving
- Scientific communication
- Leadership and mentorship
- Adaptability and resilience
- Continuous improvement mindset
Choose Duke.
At Duke, you'll find more than a job. You'll find a community committed to innovation, excellence, and improving human health.
Why Duke?
- Work alongside world-renowned clinicians, researchers, and educators.
- Contribute to pioneering neuroscience and neurosurgical discoveries.
- Join a collaborative team culture built on respect, inclusion, and shared success.
- Access extensive professional development, training, and career advancement opportunities.
- Support research that directly impacts patients and families around the world.
A Culture of Belonging
Duke is committed to fostering an environment where every individual feels valued, respected, and empowered to contribute. We believe diverse backgrounds, experiences, and perspectives fuel innovation and strengthen our ability to improve lives through research, education, and patient care.
Ready to Make a Difference?
Apply now and help advance life-changing neuroscience research while building a meaningful career with Duke University School of Medicine.
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/
Equal Opportunity Employer: Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender,gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.
Duke aspires to create a community built oncollaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions:
Nearest Major Market: Durham
Nearest Secondary Market: Raleigh