Senior Clinical Research Associate I

Role: Senior Clinical Research Associate I responsible for site management, monitoring, and close-out to ensure patient safety and study quality in accordance with GCP and Pfizer standards. Objectives: facilitate effective trial execution, maintain investigator engagement, and ensure compliance across clinical sites. Responsibilities: oversee site setup, conduct remote and onsite monitoring, manage protocol adherence, support site training, troubleshoot enrollment and data issues, and collaborate on safety reporting and audit readiness. Qualifications: bachelor’s degree in life sciences or related field; minimum 3 years’ clinical research monitoring experience, preferably in Oncology; thorough knowledge of ICH/GCP, FDA regulations, and global clinical trial processes; proficiency in clinical trial methodologies and site management. High-Value: experience in Oncology or Infectious Diseases, global trial site oversight, advanced understanding of regulatory and operational standards, and capability to support sponsor inspections. Work setup: extensive travel (60-80%), including potential international travel; requires a valid driver’s license and passport.