Clinical Research Specialist, Senior - Duke Cancer Institute

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's National Clinical Trials Network (NCTN) Clinical Research Program is seeking a Clinical Research Specialist, Senior to join the Oncology Clinical Research Unit (CRU). In this role, you will play a critical part in supporting cancer clinical trials that advance groundbreaking research and improve patient outcomes.

You will work closely with study teams to manage clinical research data, maintain study documentation, and ensure compliance with research protocols, regulatory requirements, and institutional standards. This position is ideal for a detail-oriented professional who enjoys working with data, collaborating with multidisciplinary teams, and contributing to innovative oncology research.

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 the required experience.
• Strong organizational and time management skills.
• Critical thinking and problem-solving abilities.
• Ability to accurately manage and document clinical research data.
• Effective verbal and written communication skills.

Preferred Qualifications

• Bachelor's degree strongly preferred.
• Previous experience supporting clinical research studies or clinical trials.
• Experience with Electronic Data Capture (EDC) systems and electronic Case Report Forms (eCRFs).
• Familiarity with Good Clinical Practice (GCP), FDA regulations, and human subject protection requirements.
• Experience working in oncology research or an academic medical center environment.
• Demonstrated attention to detail and commitment to data quality.

Other Requirements

• Maintain all Duke and protocol-specific training, certifications, and research compliance requirements.
• Ability to handle and process biological research specimens according to protocol requirements.
• Ability to work onsite in support of clinical research operations.

Be Bold.

As a Clinical Research Specialist, Senior, you will:

• Manage clinical research data activities by entering, reviewing, validating, and maintaining study data within Electronic Data Capture systems while ensuring data accuracy, completeness, security, and regulatory compliance.
• Complete and maintain study documentation including paper and electronic Case Report Forms (CRFs and eCRFs), source documentation, study files, participant records, and regulatory documents according to protocol and Standard Operating Procedures.
• Support participant research activities by screening participants for eligible studies, facilitating consent activities for minimal-risk protocols, scheduling study visits, preparing study materials, and maintaining participant documentation.
• Monitor and resolve data discrepancies by independently investigating incomplete, inaccurate, or missing information, coordinating with study teams, and implementing quality assurance procedures to maintain high-quality research data.
• Process and manage research specimens by collecting, preparing, shipping, tracking, and maintaining specimen inventories in accordance with protocol requirements and laboratory standards.
• Collaborate with multidisciplinary teams including investigators, clinical research staff, sponsors, and regulatory personnel to support protocol implementation, address routine study issues, and ensure successful trial execution.
• Promote ethical research conduct by adhering to federal regulations, institutional policies, Good Clinical Practice guidelines, human subject protection standards, and research participant safety requirements.
• Contribute to continuous improvement efforts by participating in team meetings, committees, educational opportunities, and collaborative initiatives that strengthen research operations and professional development.

Choose Duke.

The Duke Cancer Institute is one of the nation's leading cancer centers, bringing together world-class clinicians, researchers, and healthcare professionals committed to advancing cancer prevention, treatment, and survivorship. The Oncology Clinical Research Unit supports a robust portfolio of clinical trials that provide patients access to innovative therapies while helping shape the future of cancer care.

As part of the National Clinical Trials Network Clinical Research Program, you will work alongside dedicated professionals who are passionate about scientific discovery, collaboration, and excellence. This role offers the opportunity to contribute directly to research that impacts patients locally and globally while building your career within one of the country's premier academic health systems.