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Catalyst Clinical Research · 1 month ago

Senior Clinical Research Associate

United States

Full-time

Remote

Senior Level

5+ years exp

Catalyst Clinical Research provides customizable solutions to the biopharmaceutical and biotechnology industries. As a Senior Clinical Research Associate, you will monitor clinical trial programs and manage regional clinical trial sites to support biological and pharmaceutical developmental programs in compliance with relevant regulations.

Pharmaceutical

No H1B

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

Internal support is provided 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

Qualification

Clinical trial monitoringRegulatory complianceOncology clinical trialsClinical research methodologyOrganizational skillsTime managementComputer applicationsCommunication skillsInterpersonal skillsFlexibility

Required

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