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MSD Sr Clinical Research Associate 
Argentina, Autonomous City of Buenos Aires, Buenos Aires 
490553605

08.12.2024

Job Description

Responsibilities:

  • Develop strong site relationships and ensure continuity throughout all phases of the trial.

  • Perform clinical study site management activities in compliance with ICH-GCP, Sponsor SOPs, local laws & regulations, and protocol requirements.

  • Gain in-depth understanding of study protocols and related procedures.

  • Coordinate and manage tasks in collaboration with other sponsor roles to achieve site readiness.

  • Conduct remote and on-site monitoring activities to ensure data accuracy and subjects' safety.

  • Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.

  • Communicate with investigators and site staff on protocol conduct, recruitment, retention, and regulatory compliance.

  • Identify and resolve site performance, quality, or compliance issues in collaboration with relevant stakeholders.

  • Work collaboratively with internal teams and external partners in support of assigned sites.

  • Manage and maintain information and documentation in various systems.

  • Contribute to CRA team knowledge by acting as a subject matter expert, sharing best practices, and providing training as needed.

  • Support audit and inspection activities as required.

  • Contribute to the identification and development of new potential sites.

Requirements:

  • Minimum 4 years of direct site management (monitoring) experience in bio/pharma/CRO.

  • Fluent in local languages and English (verbal and written) with excellent communication skills.

  • Excellent understanding of clinical research, GCP/ICH guidelines, and country-specific regulations.

  • Demonstrated ability to mentor and lead.

  • Strong IT skills and ability to adapt to new applications.

  • Ability to analyze data/metrics and take appropriate action.

  • Experience with site motivational visits to boost enrollment.

  • Capable of managing complex issues and implementing corrective action.

  • B.A./B.S. with strong emphasis in science and/or biology preferred.

Why Join Our Team:

  • Opportunity to work in a dynamic and growing company at the forefront of clinical research.

  • Collaborative and supportive work environment.

  • Growth and development opportunities.

  • Competitive salary and benefits package.

Current Contingent Workers apply


No Travel Required

Not Indicated


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