Clinical Research Specialist, Senior - Duke Cancer Institute

Duke Careers•Durham, NC

1d•$21 - $31

About The Position

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.

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)
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

Nice To Haves

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

Responsibilities

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