Conduct selection, initiation, monitoring, and close-out visits in line with GCP and ICH guidelines.
Collaborate with sites to develop and track recruitment plans, ensuring project needs are met.
Provide protocol and study training to sites, maintaining regular communication to manage expectations and address issues.
Assess site practices for protocol adherence and regulatory compliance, escalating quality issues as needed.
Oversee regulatory submissions, recruitment, enrollment, CRF completion, and data query resolution.
Ensure all site documents are filed in the Trial Master File (TMF) and Investigator’s Site File (ISF) per GCP/ICH and local regulations.
Generate visit reports, follow-up letters, and other necessary documentation.
Mentor clinical staff through co-monitoring and training visits.
Work closely with study team members to support project execution.

BS degree required; a degree in a scientific discipline or healthcare is preferred.
3+ years of on site oncology monitoring experience strongly preferred.
1.5+ years of oncology monitoring experience can be considered.
Phase 1 oncology experience is required.
Proficient in GCP and ICH guidelines.
Strong therapeutic and protocol knowledge in Phase 1 oncology trials.
Excellent computer skills, including Microsoft Office and mobile devices.

Senior Clinical Research Associate, Oncology

Key skills