Senior Clinical Research Associate I (SCRA I)
Pfizer INC · 🌍 Argentina - Remote · Remote
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About the role
Why This Role Matters Are you ready to take your monitoring expertise to the next level and mentor the next generation of clinical research professionals? As a Senior Clinical Research Associate I (SCRA I), you will oversee site management, monitoring, and close-out operations for assigned clinical trials with a higher level of accountability and operational judgment. In addition to driving patient safety and trial quality, you will serve as a Subject Matter Expert (SME), contribute to regional process improvements, and partner directly with Site Care Partners (SCPs) on early-phase activation activities. Your deep therapeutic insight and leadership will directly safeguard trial integrity, strengthen crucial investigator relationships, and enhance Pfizer's scientific credibility with global external stakeholders. The Impact You Will Make In this senior-level role, you will take on expanded operational and mentorship responsibilities: · Advanced Monitoring & Site Management: Independently manage and monitor assigned investigator sites from initiation to database lock. Ensure compliance with Study Monitoring Plans, SOPs, GCP guidelines, and prevailing laws. · Site Activation & Preparation: 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). · Leadership & Mentorship: Actively mentor and train Clinical Research Associates (CRAs) as assigned, supporting their development and operational capability. · Subject Matter Expertise: Serve as a Subject Matter Expert (SME) for CRA-related processes and participate in regional or local working groups and process improvement initiatives. · Issue Resolution & Compliance: 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. · Collaborative Partnerships: Partner with SCPs, Country SOMs, Clinicians, Recruitment Specialists, and Clinical Data Scientists. Provide enrollment support, address complex protocol inquiries, and conduct remote assessment of e-diary data. · Quality Oversight: 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. What You Bring · Education: Bachelor’s degree in Life Sciences, or a professional degree in nursing, pharmacy, medical background, or equivalent. · Core Knowledge: Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations. · Experience: Minimum of 3 years of relevant experience in clinical research site monitoring (with a preference for 2 years of experience in Oncology). · Global Exposure: Prior global clinical trial experience is required. · Language Skills: Fluency in English and the native language(s) of the country you will work in. · Preferred Experience: Therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases. Key Skills : · Advanced knowledge of clinical R&D operational elements (monitoring, data acquisition, cleaning, and reporting). · Demonstrated ability to support sponsor regulatory inspections/interactions and protocol design/feasibility processes. · Proven ability to work in a matrix environment, influence stakeholders, and lead through others. · Advanced analytical capacity to interpret complex data and support risk management. Work Schedule, T