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