Senior Clinical Research Associate

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Catalyst Clinical Research

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Clinical Operations Services • Clinical Resourcing/Staffing • Clinical Teams • Functional Service Provider

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

Description

• Monitor clinical trial programs and manage regional clinical trial sites. • Ensure compliance with relevant regulations including ICH/GCP and PhRMA guidelines. • Collaborate with clinical research team for site selection and study initiation. • Travel up to 80% within an assigned territory to monitor clinical trials. • Communicate status and resolve study related issues with site staff. • Assist with Investigator Meetings planning and FDA submission preparations.

Requirements

• Bachelor’s degree in a science or health-related discipline or equivalent of 7 years industry experience. • Minimum of 5 years’ experience in clinical research with direct site monitoring experience with a sponsor company or CRO and 3 years of recent oncology clinical trial experience. • Strong knowledge of clinical trial monitoring, regulatory compliance, clinical research methodology and all applicable regulations and guidelines. • Strong organizational and time management skills and the ability to work independently. • Excellent communication and interpersonal skills. • Flexibility and ability to travel routinely to meet project requirements. • Strong knowledge of standard computer applications.