Clinical Research Specialist, Senior - Duke Cancer Institute

About the role

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 Lymphoma Clinical Research Team (CRT).

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

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)
• 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
• 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

Qualifications

• 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

Skills

• Detail-oriented
• Highly organized
• Passionate about contributing to life-saving oncology research

Benefits

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.

Pay

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/

Schedule

Not specified

Application Instructions

Not specified

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, sex (including pregnancy and pregnancy- related conditions), sexual orientation, or military status.