Clinical Research Specialist, Senior - Duke Cancer Institute

Position Summary

The Duke Cancer Institute's Thoracic Clinical Research Program is looking for a Senior Clinical Research Specialist to join the Oncology Clinical Research Unit (CRU). In this role, you will be a critical part of the research team supporting thoracic oncology clinical trials, ensuring studies are conducted safely, ethically, and in full compliance with protocol and regulatory requirements. Your work will support participant enrollment, study operations, and accurate data collection.

• Support study operations, study startup, and site management
  • Screen participants for eligibility and conduct informed consent for minimal risk studies
  • Maintain accurate and complete subject- 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 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 high-quality 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 protocol-related questions and elevate 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 protocol-specific requirements
  • Maintain required training and certifications

• 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

• 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

• 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

Job Code:  CLINICAL RESEARCH SPECIALIST, SR

Job Level: 09

Anticipated Pay Range: USD $20.76 to $31.44 per year. Duke University considers factors such as 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 goes beyond 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: (Use the "Apply for this Job" box below)./

Equal Opportunity

Employer:

Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, (including pregnancy and pregnancy‑related conditions), sexual orientation, or military status.

Essential Physical

Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and reasonable accommodation(s) can be requested with Duke Access and Accommodations Services (email: DAAS; phone: ).