Catalyst Clinical Research is hiring a
Senior Clinical Research Associate in Worldwide

Summary

The job is for a Senior Clinical Research Associate in oncology CRA, focusing on colorectal, pancreatic or advanced solid tumor. The role involves monitoring clinical trial programs, managing regional clinical trial sites, and collaborating with an assigned team. Travel up to 80% within an assigned territory is required.

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. We are unable to sponsor or take over sponsorship of an employment visa

Responsibilities

• Monitor clinical trial programs and manage regional clinical trial sites to support biological and pharmaceutical developmental programs
• Collaborate with an assigned clinical research team to provide input on site selection, study initiation procedures, conflict resolution, and audit responses
• Communicate all relevant and important findings with appropriate in-house personnel
• Travel up to 80% within an assigned territory, monitor clinical trials according to monitoring plans to achieve project goals; conduct site evaluations, study initiations, routine monitoring, site close-outs, and FDA audit preparations
• Develop territory to broaden selection of research study sites
• Communicate 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
• Provides internal support to the Field Monitor from the assigned Clinical Trial Associate
• Works closely with the extended study team including the Sponsor, Vendors, Data Manager(s), Statistician, Medical Monitor and other trial staff

Benefits

Catalyst Clinical Research, LLC is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees