Entry-Level Clinical Research Specialist, Oncology

Duke Clinical Research Institute; Durham (NC); On-site; USD 32,000 - 48,000; Full time

Job summary

The Duke Cancer Institute's National Clinical Trials Network (NCTN) Clinical Research Program is seeking a Clinical Research Specialist, Senior to join the Oncology Clinical Research Unit. You will support cancer clinical trials by managing data, maintaining study documentation, and ensuring compliance with protocols and regulatory standards in a collaborative, multidisciplinary team.

This entry-level oriented role emphasizes data integrity, documentation accuracy, and adherence to GCP

Qualifications

• Associate's degree.
• One year of relevant experience.
• Completion of the DOCR North Carolina State Approved Clinical Research Pre-Apprenticeship Program may substitute for the required experience.
• Strong organizational and time management skills.
• Critical thinking and problem-solving abilities.
• Ability to accurately manage and document clinical research data.
• Effective verbal and written communication skills.

Responsibilities

• Manage clinical research data activities by entering, reviewing, validating, and maintaining study data within Electronic Data Capture systems while ensuring data accuracy, completeness, security, and regulatory compliance.
• Complete and maintain study documentation including paper and electronic Case Report Forms (CRFs and eCRFs), source documentation, study files, participant records, and regulatory documents according to protocol and Standard Operating Procedures.
• Support participant research activities by screening participants for eligible studies, facilitating consent activities for minimal-risk protocols, scheduling study visits, preparing study materials, and maintaining participant documentation.
• Monitor and resolve data discrepancies by independently investigating incomplete, inaccurate, or missing information, coordinating with study teams, and implementing quality assurance procedures to maintain high-quality research data.
• Process and manage research specimens by collecting, preparing, shipping, tracking, and maintaining specimen inventories in accordance with protocol requirements and laboratory standards.
• Collaborate with multidisciplinary teams including investigators, clinical research staff, sponsors, and regulatory personnel to support protocol implementation, address routine study issues, and ensure successful trial execution.
• Promote ethical research conduct by adhering to federal regulations, institutional policies, Good Clinical Practice guidelines, human subject protection standards, and research participant safety requirements.
• Contribute to continuous improvement efforts by participating in team meetings, committees, educational opportunities, and collaborative initiatives that strengthen research operations and professional development.

Skills

Organizational skills

Time management

Critical thinking

Communication skills

Education

Associate's degree

Bachelor's degree strongly preferred

Tools

EDC systems

eCRFs

Job description

The Duke Cancer Institute's National Clinical Trials Network (NCTN) Clinical Research Program is seeking a Clinical Research Specialist, Senior to join the Oncology Clinical Research Unit. You will support cancer clinical trials by managing data, maintaining study documentation, and ensuring compliance with protocols and regulatory standards in a collaborative, multidisciplinary team.

This entry-level oriented role emphasizes data integrity, documentation accuracy, and adherence to GCP