Senior Clinical Research Associate - Oncology

Responsibilities

• Independently monitoring Phase II–III Oncology clinical trials to ensure compliance with study protocols, ICH-GCP guidelines, and regulatory requirements.
• Conducting site initiation, routine monitoring, and closeout visits while maintaining high-quality oversight of investigative sites.
• Performing source data review (SDR), source data verification (SDV), and case report form (CRF) review to ensure accurate and inspection-ready study data.
• Building strong partnerships with investigative sites to support enrollment goals, protocol adherence, and overall study success.
• Collaborating directly with sponsors, study teams, and site personnel while providing regular updates on site performance and trial progress.

Qualifications

• 4+ years of Clinical Research Associate experience, including significant experience independently monitoring Oncology clinical trials.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, clinical trial operations, and site management best practices.
• Experience supporting Phase II and Phase III studies with responsibility for site oversight, monitoring, and issue resolution.
• Prioritized ability to conduct site initiation, interim monitoring, and closeout visits independently.
• Proven sponsor-facing communication skills and experience working directly with biotechnology or pharmaceutical clients.
• Ability to manage multiple investigative sites, prioritize competing demands, and work effectively with minimal supervision.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401k, PTO, holidays, and sick leave as required by law.