Clinical Research Coordinator II/III - ALS ResearchBe 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.
Regulatory & Participant Protection- 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.
Data Management & Quality- 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.
Scientific Contributions- 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.
Clinical Responsibilities- 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.
Leadership & Collaboration- 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.
What We're Looking ForSuccessful candidates will bring:
- 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.
Required Qualifications at this LevelEducation/TrainingWork requires graduation from an accredited BSN or an Associate Degree in Nursing or Nursing Diploma program. All registered nurses without a Bachelor degree in Nursing (or higher) are encouraged to enroll in an appropriate BSN program within two years of their start date but must complete the program within seven years of their start date. Must have current or compact RN licensure in the state of North Carolina. BLS required.
Maintain compliance with required hospital and unit specific training competencies as well as an active RN status with the North Carolina Board of Nursing (NCBON).
Exception: Registered nurses hired before September 1, 2016 are not required to enroll in a BSN program to remain in this job classification.
ExperienceTwelve months of appropriate clinical nursing experience is required.
SkillsCan easily use computing software and web based applications (e.g., Microsoft Office products and internet browsers).
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Preferred Experience- 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.
Why Duke?At Duke, you'll have the opportunity to contribute to meaningful discoveries while growing your career in one of the nation's leading academic and research environments. You'll work alongside passionate professionals committed to improving health outcomes through innovative science, exceptional patient care, and collaborative teamwork.
Choose Duke.Ready to Make a Difference?Apply now and help advance innovative ALS research while building a stronger, healthier, and more connected future through discovery, compassion, and excellence.
Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $66,265.00 to USD $107,096.00. 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/
