Summary

The Senior Clinical Research Associate will monitor clinical trial programs, manage regional clinical trial sites, collaborate with a team, and ensure compliance with relevant regulations. The position requires a Bachelor's degree in a science or health-related discipline or equivalent industry experience, 5 years of clinical research experience with direct site monitoring, 3 years of recent oncology clinical trial experience, strong organizational skills, excellent communication skills, flexibility, and the ability to travel up to 80%.

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
Resolve study related issues and reply to audit findings
Partner with assigned clinical project team
Assist with Investigator Meetings planning/presentations, data collection, and FDA submission preparations
Maintain a home office if working remotely
Manage work activities in a time and cost-effective manner
Participate in internal and/or external meetings to maintain current knowledge on applicable regulations and guidelines
Collaborate closely with the Study Manager and Project Manager
Provide internal support to the Field Monitor from the assigned Clinical Trial Associate
Work closely with the extended study team including the Sponsor, Vendors, Data Manager(s), Statistician, Medical Monitor and other trial staff

Preferred Qualifications

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

Benefits

Catalyst Clinical Research, LLC is an equal opportunity employer

Catalyst Clinical Research is hiring a Senior Clinical Research Associate