Research Analyst

• Independently manage and monitor assigned investigator sites from initiation to database lock.
• Ensure compliance with Study Monitoring Plans, SOPs, GCP guidelines, and prevailing laws.
• Partner with Site Care Partners prior to site activation on crucial feasibility and site selection processes, Pre-Trial Assessments (PTAs), site activation checklists, Informed Consent Document (ICD) finalization, and Site Initiation Visits (SIVs).
• Actively mentor and train Clinical Research Associates (CRAs) as assigned, supporting their development and operational capability.
• Serve as a Subject Matter Expert (SME) for CRA-related processes and participate in regional or local working groups and process improvement initiatives.
• Identify, resolve, and manage complex investigator site issues.
• Establish and implement robust CAPAs, manage Quality Event remediations, support sponsor regulatory interactions/inspections, and drive Audit Observation CAPA developments.
• Partner with SCPs, Country SOMs, Clinicians, Recruitment Specialists, and Clinical Data Scientists.
• Monitor site-level AEs/SAEs, collaborate with the Drug Safety Unit, handle investigational product oversight (accounting, storage, destruction), support database release, and conduct co-monitoring activities as requested.

Senior Clinical Research Associate I

• Coordinate and support clinical trial activities, assisting managers in their execution.
• Contribute to project tasks and milestones, organizing work to meet deadlines.
• Work in a structured environment using established procedures, seeking guidance from colleagues.
• Maintain the Pfizer Trial Master File (PTMF) in compliance with ICH-GCP and SOPs, and ensure team members update tracking and files as needed.
• Timely update trial and site information in the Corporate Clinical Trial Registry and support Clinical Trial Applications to ethics committees and regulatory authorities.
• Provide administrative support for protocols and Informed Consent Documents (ICD) to global Project Managers and Study Managers, assisting with activities within set timelines.
• Develop and maintain local tracking spreadsheets for study-related documents, data, and activities, prepare supportive materials for sites, attend training programs, and identify process improvements for inspection readiness and PTMF compliance.

Clinical Research Associate, CRA

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process
• Collaborating with investigators and site staff to facilitate smooth study conduct
• Performing data review and resolution of queries to maintain high-quality clinical data
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports

Research Analyst jobs in Argentina

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Senior Clinical Research Associate I

Clinical Research Associate, CRA

Clinical Research Associate II