Clinical Research Specialist, Senior - Duke Cancer Institute
About The Position
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.
Requirements
- Associate’s degree
- One year of relevant clinical research or related experience
- Completion of the DOCR North Carolina state-approved Clinical Research Pre‑Apprenticeship program may substitute for one year of experience
- Basic Life Support (BLS) certification from the American Heart Association or Duke‑approved equivalent (required)
- Ability to work onsite in a clinical research environment
- This position is onsite
Nice To Haves
- 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
Responsibilities
- Support study operations, study start‑up, and site management
- Screen participants for eligibility and conduct informed consent for minimal risk studies
- Maintain accurate and complete subject‑level and study‑level 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, process, prepare, ship, and track biological research specimens
- Maintain specimen inventories in compliance with protocol and institutional requirements
- 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
- Respond to routine protocol‑related 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
- 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
- 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 protocol-specific requirements
- Maintain required training and certifications
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
Number of Employees
101-250 employees
