Senior Clinical Research Associate

Summary

Join Catalyst Clinical Research as a Senior Clinical Research Associate to monitor clinical trial programs and manage regional clinical trial sites. You will collaborate with a clinical research team, providing input on site selection and study procedures. Responsibilities include extensive travel, monitoring clinical trials, communicating findings, and assisting with various aspects of study management. The ideal candidate possesses a Bachelor's degree in a science or health-related field or equivalent experience, along with significant clinical research experience, particularly in oncology. Strong organizational, communication, and time management skills are essential. This position requires extensive travel.

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
• Applicants must be authorized to work for ANY employer in the U.S

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
• Works closely with the extended study team including the Sponsor, Vendors, Data Manager(s), Statistician, Medical Monitor and other trial staff