Catalyst Clinical Research is hiring a
Senior Clinical Research Associate, Remote - Worldwide
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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
This job is filled or no longer available
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