Remote Senior Clinical Research Associate

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

• 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

• 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