Senior Clinical Research Associate I

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💰 Post-IPO Debt on 2023-05

We’re celebrating 175 years of daring scientific innovation—and we’re not done yet. Every day, we’re channeling our passion and resources into delivering innovative therapies that change the face of healthcare. Let’s outdo yesterday.

📋 Description

• 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

• 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

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