Catalyst Clinical Research is hiring a
Senior Clinical Research Associate, Remote - Worldwide

Summary

The job is for a Senior Clinical Research Associate who will monitor clinical trial programs, manage regional clinical trial sites, and collaborate with an assigned clinical research team. The role requires travel up to 80%, strong knowledge of clinical trial monitoring, regulatory compliance, and excellent communication skills.

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

Responsibilities

• Monitor clinical trial programs and manage regional clinical trial sites
• Collaborate with an assigned clinical research team
• Provide input on site selection, study initiation procedures, conflict resolution, and audit responses
• Communicate all relevant findings with appropriate in-house personnel
• Travel up to 80% within an assigned territory
• Conduct or assist with site evaluations, study initiations, routine monitoring, site close-outs, and FDA audit preparations
• Develop territory to broaden selection of research study sites
• Effectively communicate with site study staff and Catalyst clinical research personnel
• Report study site status, disseminate information to the appropriate individuals, and resolve study related issues
• Participate in internal and/or external meetings to maintain current knowledge on applicable regulations and guidelines

Preferred Qualifications

Experience with Investigator Meetings planning/presentations, data collection, and FDA submission preparations

Benefits

Works remotely if needed, requires maintaining a home office