Senior Clinical Research Associate

November 9

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Catalyst Clinical Research

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

201 - 500

Description

• Monitor clinical trial programs and manage regional clinical trial sites. • Support biological and pharmaceutical developmental programs in a manner consistent with ICH/GCP and PhRMA guidelines. • Collaborate with an assigned clinical research team for site selection, study initiation, and audit responses. • Travel up to 80% within an assigned territory. • Conduct site evaluations, study initiations, routine monitoring, and FDA audit preparations. • Communicate with site study staff and Catalyst clinical research personnel to report study site status. • Manage work activities to ensure budgetary guidelines and project timelines are met. • Participate in meetings to maintain current knowledge on regulations and guidelines.

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.