Senior Clinical Research Associate I

🕒 July 16

🇦🇷 Argentina – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 50%

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Pfizer

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1849

💼 Consulting

📣 Marketing

💊 Pharmaceuticals

💰 Post-IPO Debt on 2023-05

Consulting • Marketing • Pharmaceuticals

Pfizer is a pharmaceutical company that has been at the forefront of scientific innovation for 175 years. The company is dedicated to improving health and well-being at every stage of life by providing access to safe, effective, and affordable medicines and healthcare services. Pfizer focuses on delivering innovative therapies, particularly in the field of cancer treatments, as it continues to progress in transforming the healthcare landscape.

📋 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 on feasibility, site selection, Pre-Trial Assessments, activation checklists, Informed Consent Document finalization, and Site Initiation Visits • Mentor and train Clinical Research Associates • Serve as a Subject Matter Expert for CRA-related processes • Participate in regional or local working groups and process improvement initiatives • Identify, resolve, and manage complex investigator site issues • Establish and implement CAPAs and manage Quality Event remediations • Support sponsor regulatory interactions and inspections • Drive Audit Observation CAPA developments • Partner with Site Care Partners, Country SOMs, Clinicians, Recruitment Specialists, and Clinical Data Scientists • Provide enrollment support and address complex protocol inquiries • Conduct remote assessment of e-diary data • Monitor site-level AEs/SAEs and collaborate with the Drug Safety Unit • Oversee investigational product accounting, storage, and 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 • Prior global clinical trial experience required • Fluency in English and the native language(s) of the country you will work in • Advanced knowledge of clinical R&D operational elements, including 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 • Valid driver’s license and passport required • Significant travel commitment of 60% to 80% within the assigned area • Therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases preferred • Two years of Oncology experience preferred

🏖️ Benefits

• Medical • Significant travel within the assigned area, with occasional international and weekend travel as part of the role