Senior Clinical Research Associate I

Pfizer

Senior Clinical Research Associate managing and monitoring clinical trials from initiation to close-out in Argentina. Responsibilities include mentorship of CRAs and ensuring compliance with regulations.

Posted 7/16/2026full-timeRemote • 🇦🇷 ArgentinaSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trial processes, ensuring compliance with GCP guidelines, and mentoring Clinical Research Associates. Possesses strong knowledge of clinical trial methodologies and regulatory requirements, particularly in Oncology.

Highest-signal resume keywords

Clinical Trial MethodologiesGCP ComplianceSite Monitoring ExperienceOncology Therapeutic ExperienceRegulatory Interactions

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical ResearchSite MonitoringCAPA ImplementationQuality Event ManagementDatabase Lock ProceduresInformed Consent Document FinalizationFeasibility AssessmentSite Initiation VisitsAudit Observation ManagementInvestigational Product Oversight

Soft Skills

MentoringProblem SolvingCollaborationCommunication

Industry Keywords

ICH GuidelinesFDA RegulationsLife SciencesClinical Data ManagementOncologyVaccinesInternal MedicineInfectious Diseases

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

Bachelor’s degree in Life Sciences, or a professional degree in nursing, pharmacy, medical background, or equivalent.
Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations.
Minimum of 3 years of relevant experience in clinical research site monitoring (with a preference for 2 years of experience in Oncology).
Prior global clinical trial experience is required.
Fluency in English and the native language(s) of the country you will work in.
Therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.

Benefits

Comp & perks

Travel Commitment: This role requires significant travel (60% to 80%) within your assigned area.
A valid driver’s license and passport are required.