Oncology CRA

Responsibilities

• Conduct site selection, initiation, monitoring, and close-out visits to ensure compliance with GCP, ICH, protocol requirements, and applicable regulatory standards.
• Partner with investigative sites to develop, track, and execute patient recruitment and enrollment strategies to meet study objectives and timelines.
• Deliver protocol and study-specific training, maintain ongoing communication with site personnel, and proactively address operational issues and risks.
• Monitor study conduct and site performance, assess protocol adherence, identify quality concerns, and escalate issues to support regulatory compliance and data integrity.
• Track study milestones including regulatory submissions, site activation, patient recruitment, enrollment, and data management activities to ensure successful study execution.
• Maintain essential trial documentation within TMF and ISF files, support site financial management and invoice processing, and mentor clinical staff through training, co-monitoring, and collaborative study support.

Qualifications

• Bachelor’s degree in a scientific, life sciences, healthcare, or related discipline preferred.
• Minimum of 3 years of recent on-site clinical monitoring experience in Oncology, with direct experience supporting Phase I studies involving solid and/or liquid tumor indications; this requirement is mandatory.
• Strong knowledge of Good Clinical Practice (GCP), ICH guidelines, regulatory requirements, and oncology clinical trial protocols.
• Proven ability to independently manage investigative sites, monitor study conduct, ensure protocol compliance, and maintain high standards of data quality and patient safety.
• Proficiency with Microsoft Office applications, along with excellent communication, organizational, problem-solving, and relationship-management skills.
• Demonstrated ability to effectively manage timelines, budgets, and competing priorities while building strong collaborative partnerships with investigators, site personnel, and cross-functional study teams.

Pay

Salary Range: $120,000 – $130,000, depending on experience

Benefits

Full Comprehensive Benefits: Health, Vision, Dental, PTO, Paid Holiday and Sick Leave if Required by Law