Associate Clinical Research Associate (CRA) / CRA at MSD, Apply Now!
Join MSD as an Associate Clinical Research Associate (CRA) or Clinical Research Associate (CRA) and make a significant impact in clinical trials. You will be accountable for ensuring compliance with clinical study protocols, managing site relationships, and overseeing study performance across all phases. With opportunities for growth, this role offers you the chance to work on diverse projects and develop new clinical research sites, all while adhering to the highest standards of ICH/GCP and company regulations.
Job Requirements
The opportunities
As an ACRA or CRA at MSD, you will be accountable for performance and compliance for assigned protocols and sites in a country. You will ensure compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards, and adverse event reporting requirements. You will act as the primary site contact and site manager, taking overall responsibility for allocated sites. You will also actively develop and expand the territory for clinical research, finding and developing new sites.
Responsibilities:
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Site Relationship Management: Develop and maintain strong relationships with clinical trial sites throughout all trial phases, ensuring continuity and smooth operations.
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Study Protocol Compliance: Monitor and ensure compliance with ICH-GCP, Sponsor SOPs, local regulations, and protocol requirements.
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Monitoring Activities: Perform remote and on-site monitoring visits, ensuring data accuracy, subject safety, and protocol adherence.
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Site Visits & Documentation: Conduct various site visits (validation, initiation, monitoring, close-out), recording clear and comprehensive reports.
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Regulatory Documentation Management: Oversee the collection and review of regulatory documentation for study start-up, maintenance, and close-out phases.
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Site Performance & Compliance: Identify and resolve site performance issues, escalating to management as necessary.
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Collaboration: Work with various teams (GCTO, finance, pharmacovigilance, etc.) to support site operations and ensure regulatory compliance.
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Knowledge Sharing: Act as a process Subject Matter Expert (SME), sharing best practices with the CRA team.
Qualification & Skills:
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Experience: Minimum of 1 year of direct site monitoring experience for the Associate CRA role, or 2 years for the CRA role.
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Educational Background: B.A./B.S. in science or biology (preferred).
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Language Skills: Fluent in local languages and English, with excellent communication skills.
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Technical Skills: Proficiency in MS Office and various clinical IT applications, including on mobile devices.
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Knowledge of Clinical Research: Solid understanding of clinical trial phases, GCP/ICH guidelines, and relevant regulations.
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Monitoring Skills: Demonstrated independent professional judgment and strong monitoring abilities.
Keywords: Clinical Research Associate, CRA, Associate CRA, MSD, Clinical Trials, Biopharmaceutical, ICH/GCP, Site Monitoring, Protocol
