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 Thoracic Clinical Research Program is looking for a Senior Clinical Research Specialist to join our Oncology Clinical Research Unit (CRU). In this role, you will be a critical part of the research team supporting thoracic oncology clinical trials, helping ensure studies are conducted safely, ethically, and in full compliance with protocol and regulatory requirements.

Every day, you will contribute directly to advancing cancer research by supporting participant enrollment, managing study operations, and ensuring the accuracy and integrity of clinical research data. If you enjoy structured, detail-oriented work, collaborating with multidisciplinary teams, and supporting research that improves patient outcomes, this role offers a meaningful and engaging opportunity.

Minimum Requirements

• Associate's degree
• One year of relevant clinical research or related experience




• Completion of the DOCR North Carolina state-approved Clinical Research PreApprenticeship program may substitute for one year of experience

Preferred Qualifications

• Bachelor's degree strongly preferred
• Experience working in oncology or clinical research settings
• Familiarity with electronic data capture (EDC) systems
• Strong documentation, organization, and communication skills

Other Requirements

• Basic Life Support (BLS) certification from the American Heart Association or Dukeapproved equivalent (required)
• Ability to work onsite in a clinical research environment
• This position is onsite

Be Bold.

As a Senior Clinical Research Specialist, you will support daytoday clinical research operations across multiple thoracic oncology studies. Key responsibilities include:

• Support study operations, study startup, and site management




• Screen participants for eligibility and conduct informed consent for minimal risk studies
• Maintain accurate and complete subjectlevel and studylevel documentation
• Schedule participants for study visits and prepare required materials according to study protocols and SOPs
• Assist with defining and maintaining source documentation
• Follow procedures for study payments and financial documentation

• Collect and manage clinical research specimens




• Collect, process, prepare, ship, and track biological research specimens
• Maintain specimen inventories in compliance with protocol and institutional requirements

• Ensure highquality data collection and documentation




• Enter study data accurately using EDC systems and other clinical research technologies
• Complete paper and electronic Case Report Forms (CRFs/eCRFs) according to protocol
• Run reports and summaries to support data review activities
• Independently resolve missing, incomplete, or inaccurate data
• Follow SOPs and institutional processes for data quality assurance, security, and provenance
• Recognize and report vulnerabilities related to physical or electronic data security

• Communicate effectively with study teams




• Respond to routine protocolrelated questions and escalate issues as appropriate
• Coordinate with investigators, CRU leadership, and study personnel to support efficient study conduct
• Contribute to routine problem resolution during study implementation

• Demonstrate leadership and professionalism




• Actively participate in team meetings, committees, task forces, and ad hoc groups
• Support colleagues and contribute to group success
• Proactively seek continuing education and professional development opportunities

• Uphold ethics and regulatory compliance




• Apply professional guidelines and ethical principles governing clinical research
• Understand and prioritize participant safety
• Identify and explain risks and benefits associated with clinical trials
• Follow all Duke policies, SOPs, regulatory requirements, and protocolspecific requirements
• Maintain required training and certifications

Choose Duke.

The Duke Cancer Institute is one of the nation's leading centers for cancer research and patient care. By joining the Oncology Clinical Research Unit within the Thoracic Clinical Research Program, you become part of a collaborative, missiondriven team dedicated to advancing discoveries that improve the lives of patients with cancer.

At Duke, you will work alongside worldclass investigators, clinicians, and research professionals in an environment that values excellence, integrity, teamwork, and continuous learning. Duke offers a strong culture of professional development, access to cuttingedge research infrastructure, and the opportunity to build a meaningful career in clinical research.