Clinical Research Nurse Coordinator
$66.27k - $107.1kDuke University
School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.
Be You. Be Bold. Choose Duke. Clinical Research Coordinator II/III - ALS Research Be You. At Duke, we celebrate individuality and the unique perspectives that each member of our community brings. As a Clinical Research Coordinator , you'll play a critical role in advancing groundbreaking research that aims to improve the lives of individuals living with Amyotrophic Lateral Sclerosis (ALS). You'll join a collaborative team of physicians, researchers, nurses, and clinical professionals dedicated to conducting complex clinical studies while delivering exceptional participant care.This role is ideal for someone who thrives in a fast-paced environment, enjoys balancing multiple priorities, and is passionate about clinical research excellence. Be Bold. Join a team conducting innovative and complex clinical research studies that have the potential to change lives. You'll serve as a key contributor across all phases of clinical trial operations, participant engagement, data management, regulatory compliance, and investigational product management. What You'll Do: Research Operations & Study Management
- Coordinate and manage complex clinical research studies, including procedural and interventional protocols.
- Identify when MTAs, CDAs, DUAs, DTAs, and other research agreements are required and engage appropriate stakeholders.
- Maintain study-level documentation and regulatory files for domestic and international studies.
- Manage all aspects of Investigational Product (IP) accountability, including receipt, storage, tracking, dispensing, and reconciliation.
- Serve as the primary liaison between sponsors, Investigational Drug Services (IDS), research teams, and external collaborators.
- Support study monitoring visits, sponsor audits, inspections, and quality reviews while ensuring corrective actions are implemented when needed.
- Coordinate participant recruitment, screening, enrollment, retention, and study visit activities.
- Develop and implement study-specific operational workflows, tools, and standard operating procedures.
- Prepare studies for closeout activities and long-term documentation storage.
- Conduct informed consent discussions and documentation for a broad range of clinical studies, including higher-risk and interventional protocols.
- Prepare, submit, and maintain regulatory documentation through IRB systems and institutional processes.
- Collaborate with principal investigators to evaluate, document, and report adverse events and safety information.
- Support sponsor and regulatory agency reporting requirements.
- Ensure studies remain compliant with institutional policies, Good Clinical Practice (GCP), protocol requirements, and applicable regulations.
- Collect, enter, manage, and validate research data across multiple research systems.
- Ensure data quality, accuracy, completeness, and regulatory compliance.
- Support development of data collection tools, case report forms, and quality assurance processes.
- Apply research data standards and best practices, including FAIR data principles and data-sharing requirements.
- Create reports, dashboards, visualizations, and study summaries to support investigators and stakeholders.
- Assist with preparation of datasets and documentation for publication and repository submission.
- Conduct literature reviews and support protocol development activities.
- Contribute to research manuscripts, conference presentations, abstracts, posters, and publications.
- Assist investigators with grant submissions and research proposal development.
- Apply scientific and clinical knowledge to research study execution and problem-solving.
- Administer adult medications in accordance with study and institutional requirements.
- Perform peripheral intravenous (IV) insertion and maintenance.
- Operate and manage Alaris infusion pumps.
- Obtain blood samples from arterial lines.
- Support protocol-required clinical procedures and participant assessments.
- Serve as a trusted resource for study teams and research partners.
- Train, mentor, and support research staff as needed.
- Participate in committees, workgroups, and professional development opportunities.
- Build effective relationships across departments, sponsors, CROs, and research stakeholders.
- Demonstrate adaptability, initiative, and strong organizational awareness to advance research objectives.
- Experience coordinating clinical research studies, preferably involving complex or interventional protocols.
- Strong knowledge of clinical research regulations, IRB processes, and research documentation requirements.
- Experience with participant recruitment, retention, and study coordination.
- Excellent organizational and multitasking abilities.
- Strong communication and relationship-building skills.
- Experience with IV placement and related clinical procedures.
- Proficiency using clinical research management systems, EHR platforms, and research databases.
- Ability to manage competing priorities while maintaining exceptional attention to detail.
- Experience working with neurological disorders, ALS, or related therapeutic areas.
- Experience with OnCore, eReg, and other clinical research systems.
- Knowledge of investigational product management and clinical trial operations.
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:
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:
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 reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: View email address on click.appcast.io; phone: View phone number on click.appcast.io).
$66.27k - $107.1k
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