Senior Oncology Clinical Research Specialist

Duke Clinical Research Institute; Durham (NC); On-site; USD 48,000 - 72,000; Full time

Job summary

Duke Clinical Research Institute, part of the Duke Cancer Institute, is seeking a Clinical Research Specialist, Senior to join the Oncology Clinical Research Unit. You will support cancer clinical trials, manage data, maintain study documentation, and ensure protocol and regulatory compliance.

The role emphasizes meticulous data handling, collaboration with multidisciplinary teams, and adherence to GCP and FDA regulations. Onsite work and EDC/eCRFs experience are valued for success in this role.

Qualifications

• Associate's degree required; one year of related experience preferred.
• Strong organizational and time management skills are essential.
• Experience with EDC and eCRFs is desirable.
• Familiarity with GCP, FDA regulations, and human subject protection is a plus.

Responsibilities

• Manage clinical research data activities in EDC systems with accuracy and compliance.
• Complete and maintain study documentation including CRFs/eCRFs and regulatory files.
• Support participant research activities by screening and coordinating visits as needed.
• Monitor data quality, resolve discrepancies, and coordinate with study teams.
• Process and manage research specimens per protocol and lab standards.
• Collaborate with investigators, sponsors, and regulatory personnel to support protocol implementation.
• Promote ethical research conduct and adherence to regulatory guidelines.
• Contribute to continuous improvement through team participation and training.

Skills

Clinical data management

Regulatory compliance

Study documentation

Communication

Education

Associate's degree

Tools

EDC systems

eCRFs

Job description

Duke Clinical Research Institute, part of the Duke Cancer Institute, is seeking a Clinical Research Specialist, Senior to join the Oncology Clinical Research Unit. You will support cancer clinical trials, manage data, maintain study documentation, and ensure protocol and regulatory compliance.

The role emphasizes meticulous data handling, collaboration with multidisciplinary teams, and adherence to GCP and FDA regulations. Onsite work and EDC/eCRFs experience are valued for success in this role.