Remote Senior Clinical Research Associate
Catalyst Clinical Research
๐Remote - Worldwide
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Job highlights
Summary
Join our team as a Senior Clinical Research Associate and play a crucial role in monitoring clinical trial programs, managing regional sites, and collaborating with research teams to ensure project goals are met.
Requirements
- Bachelorโs degree in a science or health-related discipline or equivalent of 7 years industry experience
- Minimum of 5 yearsโ 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
- Travels up to 80% within an assigned territory, monitors clinical trials according to monitoring plans to achieve project goals
- Conducts or assists with site evaluations, study initiations, routine monitoring, site close-outs, and FDA audit preparations
- Develops territory to broaden selection of research study sites
- Effectively communicates with site study staff and Catalyst clinical research personnel to report study site status, disseminate information to the appropriate individuals, and resolve study related issues
- Replies to audit findings
- Partners with assigned clinical project team
- Assists with Investigator Meetings planning/presentations, data collection, and FDA submission preparations
- Maintains a home office if working remotely
- Manages work activities in a time and cost-effective manner to ensure budgetary guidelines and project timelines are met
- Participates in internal and/or external meetings to maintain current knowledge on applicable regulations and guidelines
- Collaborates closely with the Study Manager and Project Manager
Benefits
Internal support is provided to the Field Monitor from the assigned Clinical Trial Associate
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