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 Hematologic Malignancies and Cellular Therapies (HMCT) Clinical Research Program within the Duke Cancer Institute’s Oncology Clinical Research Unit (CRU) is seeking a Clinical Research Specialist, Senior to support the Leukemia Clinical Research Team (CRT). In this role, you will play a key part in advancing cutting-edge clinical research in the treatment of leukemia and myeloproliferative neoplasms.

You will contribute to the day-to-day operations of clinical trials by supporting data coordination and management for the leukemia/MPN research portfolio. This role offers you the opportunity to work closely with multidisciplinary teams while ensuring the accuracy, integrity, and compliance of clinical research data. Your work will directly support innovative therapies that improve outcomes for patients with complex blood cancers.

In this role, you will have a strong focus on data management and quality. You will work extensively with electronic data systems, case report forms, and reporting tools while ensuring adherence to protocol requirements, regulatory standards, and data security practices. You may also assist with participant scheduling, specimen handling, and study documentation, contributing to the seamless execution of clinical research.

You will use required processes, policies, and systems to ensure data security and provenance.  You will independently investigate incomplete, inaccurate or missing data and documents to ensure accuracy and completeness of data. Finally, you will recognize and report vulnerabilities related to security of physical and electronic data. 

This is an excellent opportunity for someone who is detail-oriented, highly organized, and passionate about contributing to life-saving oncology research in a collaborative and mission-driven environment.

Minimum Requirements:

• Associate’s degree required
• One year of relevant clinical research or related experience required
• Completion of the DOCR North Carolina State-approved Clinical Research Pre-Apprenticeship Program may substitute for one year of experience
• Experience using basic computing software and web-based applications (e.g., Microsoft Office, internet browsers)

Preferred Qualifications:

• Previous experience with data entry in a clinical research or healthcare setting
• Familiarity with Electronic Data Capture (EDC) systems and clinical trial databases
• Comfort working with multiple software platforms and research systems
• Strong attention to detail with the ability to manage large volumes of data accurately

Other Requirements:

• Ability to follow Standard Operating Procedures (SOPs), study protocols, and regulatory requirements
• Willingness to maintain Duke and project-specific training and certifications
• Ability to handle biological specimen collection, processing, and shipment
• Strong written and verbal communication skills

Be Bold.

Position Description:

• Coordinate study operations and participant activities by screening eligible participants, obtaining and documenting consent for minimal risk studies, scheduling visits, and preparing study materials, supplies, and documentation in accordance with protocol and SOPs
• Manage study and regulatory documentation by maintaining subject-level and study-level records, assisting with study payment processes, defining source documentation, and ensuring compliance with institutional and regulatory requirements
• Perform comprehensive clinical research data management by using Electronic Data Capture (EDC) systems, technologies, and software to accurately enter study data; completing paper and electronic Case Report Forms (CRFs and eCRFs) according to protocol; and running summaries and reports on existing data
• Ensure data quality, accuracy, and security by following SOPs for data QA; using required processes, policies, and systems to ensure data security and provenance; independently investigating incomplete, inaccurate, or missing data and documents; and recognizing and reporting vulnerabilities related to the security of physical and electronic data
• Handle research specimens and materials by collecting, preparing, processing, shipping, and maintaining inventory of biological specimens in accordance with protocol and laboratory standards
• Communicate effectively with study teams by responding to routine protocol-related questions, escalating complex issues as needed, and coordinating with study personnel to support implementation and problem resolution
• Support team collaboration and leadership initiatives by actively participating in meetings, committees, and projects; supporting colleagues in their work; and pursuing professional development opportunities
• Uphold ethical standards in clinical research by adhering to professional guidelines, understanding risks and benefits of clinical trials, protecting vulnerable populations, and prioritizing participant safety at all times
• Perform other related duties as assigned

The above statements describe the general nature and level of work being performed and are not intended to be an exhaustive list of all responsibilities.

Choose Duke.

Join Duke Cancer Institute, a nationally recognized leader in cancer care, research, and innovation. Within the Hematologic Malignancies and Cellular Therapies program, you will contribute to groundbreaking clinical trials that are transforming treatment approaches for patients with complex blood cancers.

At Duke University, you will be part of a collaborative, mission-driven environment focused on discovery, excellence, and improving patient outcomes. You will work alongside world-class clinicians, researchers, and staff dedicated to advancing science and delivering exceptional care.