Clinical Research Specialist, Senior - Duke Cancer Institute at Duke Careers

Durham, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

05 Jul, 26

Salary

31.44

Posted On

06 Apr, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical research, Oncology, Data collection, Electronic data capture, Regulatory compliance, Informed consent, Specimen management, Documentation, Protocol adherence, Patient screening, Data quality assurance, Communication, Organization, Problem resolution, Basic life support

Industry

IT Services and IT Consulting

Description

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 Pre‑Apprenticeship 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 Duke‑approved 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 day‑to‑day clinical research operations across multiple thoracic oncology studies. Key responsibilities include: 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 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 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 protocol‑specific 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, mission‑driven team dedicated to advancing discoveries that improve the lives of patients with cancer. At Duke, you will work alongside world‑class 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 cutting‑edge research infrastructure, and the opportunity to build a meaningful career in clinical research. Job Code: 00000803 CLINICAL RESEARCH SPECIALIST, SR Job Level: 09 Anticipated Pay Range: Duke University provides an annual base salary range for this position as USD $20.76 to USD $31.44. Duke University considers factors such as (but not limited to) 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: https://hr.duke.edu/benefits/ 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. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. 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@duke.edu; phone: 919-668-1267).

Responsibilities

The Senior Clinical Research Specialist supports day-to-day operations for thoracic oncology clinical trials, including participant screening, informed consent, and study documentation. They are responsible for ensuring data integrity, managing biological specimens, and maintaining compliance with institutional and regulatory protocols.