CLINICAL RESEARCH COORDINATOR, SR

As the Clinical Research Coordinator, Sr - Neonatal/Perinatal (NPRU), you will play a critical role in advancing federally funded and industry-sponsored neonatal and perinatal research. Your work will directly support complex clinical studies, multidisciplinary investigations, and care for the most vulnerable patients-neonates. What You'll Do: Operations Serve as an institutional expert in FDA, IND, and international regulatory requirements, providing guidance across multiple study teams. Direct teams to appropriate Duke offices for contract execution and approval processes. Oversee investigational product (IP) management for multiple studies, including documentation, handling methods, and compliance. Develop, optimize, and manage systems for specimen collection, processing, shipping, and storage across the research program. Lead preparation for monitoring visits, audits, and regulatory inspections. Provide advanced oversight and training for participant level documentation, including DUHS billing requirements for complex interventional studies. Ethics Guide teams in accurate identification, documentation, and reporting of adverse events. Serve as a senior resource for developing and documenting consent plans for highly complex studies. Oversee IRB submissions, regulatory documentation, safety reports, and compliance with Duke and federal policies. Data Management Select and implement data capture methods for multiple studies, including building EDCs and designing eCRFs based on protocol needs. Lead quality assurance processes, data query management, and dataset reviews. Oversee CDISC/CDASH data standard setup and dataset transformation for FDA regulated studies. Develop and implement data governance and data provenance protocols across the research program. Guide teams in preparing datasets for repository submission and ensuring FAIR data principles are applied. Science & Protocol Development Independently draft grant applications, study aims, and background sections for funding proposals. Develop protocol components for multi‑PI and complex investigator‑initiated studies. Conduct literature reviews and contribute to scientific abstracts, posters, and publications. Study & Site Management Mentor teams on communication with sponsors and CROs. Oversee site initiation, monitoring, and closeout activities. Ensure protocol adherence, accurate tracking of financial milestones, and maintenance of current study documents. Forecast study needs, supplies, staffing, and workflow requirements. Leadership Lead multisite coordinator meetings for portfolio studies such as the Neonatal Research Network. Serve on Duke and external committees related to neonatal research. Lead change management efforts and facilitate process improvements across study teams. Mentor junior coordinators, fostering growth, compliance, and operational excellence. Minimum Qualifications Education: Associate's degree (Bachelor's degree may substitute for 2 years of required experience). Experience: Minimum of six years of research experience. Degrees, Licensures, Certifications: Minimum of six years of research experience; Bachelor’s degree may substitute for 2 years. Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $69,362.00 to USD $110,658.00. Duke University considers factors such as 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 goes beyond 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: Essential Physical Job Functions: Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department. Duke is an affirmative Action/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, sexual orientation, or veteran status. #J-18808-Ljbffr Duke Clinical Research Institute