Clinical Research Coordinator

Duke Careers•Durham, NC

14d•$61,026 - $101,959•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.
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.
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.
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.
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.
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.