Clinical Research Specialist, Senior - Duke Cancer institute
Duke UniversityAbout the role
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.
The Duke Cancer Institute (DCI) is seeking a Clinical Research Specialist, Sr. to join the Bone Marrow Transplant, Hematologic Malignancies, and Cellular Therapy Clinical Research Program. In this vital role, you will serve as a data coordinator supporting innovative cell therapy clinical trials that help advance groundbreaking cancer treatments and improve patient outcomes.
As a member of the Oncology Clinical Research Unit (CRU), you will play an important role in the daily management of clinical research studies, supporting the collection, documentation, quality review, and maintenance of critical clinical trial data. You will work closely with research participants, study teams, principal investigators, sponsors, and regulatory personnel to ensure research activities are conducted accurately, ethically, and in compliance with institutional, federal, and sponsor requirements.
This position offers an opportunity to develop expertise in clinical research operations, data management, participant coordination, and regulatory compliance while contributing to cutting-edge clinical trials in cellular therapy and hematologic malignancies. Your work will directly support research efforts that advance scientific discovery and improve patient care.
Minimum Requirements
- Associate's degree.
- One year of relevant experience.
- Completion of the DOCR North Carolina State Approved Clinical Research Pre-Apprenticeship Program may substitute for one year of required experience.
- Ability to effectively use computer software and web-based applications, including Microsoft Office products and internet browsers.
Preferred Qualifications
- Bachelor's degree strongly preferred.
- Experience supporting clinical research studies, clinical trials, healthcare operations, research data management, or related activities.
- Experience entering and managing data within Electronic Data Capture (EDC) systems.
- Knowledge of clinical research regulations, Good Clinical Practice (GCP), human subject protections, and Institutional Review Board (IRB) requirements.
- Strong organizational skills with the ability to manage multiple priorities and deadlines.
- Excellent written and verbal communication skills.
- Ability to identify, investigate, and resolve data discrepancies independently.
- Experience working in oncology, hematology, bone marrow transplant, cellular therapy, or related clinical research environments preferred.
Other Requirements
- Maintain all required Duke and project-specific clinical research training and certifications.
- Adhere to all institutional, regulatory, sponsor, and protocol-specific requirements governing clinical research.
- Participate in monitoring visits, audits, and research-related training activities as required.
Be Bold.
Position Description:
As a Clinical Research Specialist, Sr., you will support the conduct of clinical research studies through participant coordination, study management, d
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