Senior Clinical Research Associate I (SCRA I)

About the role

As a Senior Clinical Research Associate I you will independently manage site monitoring, activation and close‑out for assigned trials, ensuring patient safety and data quality while mentoring junior CRAs.

Key responsibilities

• Manage and monitor investigator sites from initiation through database lock, adhering to SOPs, GCP and local regulations.
• Partner with Site Care Partners on feasibility, pre‑trial assessments, consent documents and site initiation visits.
• Mentor and train assigned CRAs, supporting their professional development.
• Serve as a Subject Matter Expert, contribute to regional process improvements and work‑group initiatives.
• Identify and resolve complex site issues, implement CAPAs, and support regulatory inspections.

Required profile

• Bachelor’s degree in Life Sciences or related professional degree (nursing, pharmacy, medical).
• Minimum 3 years of clinical research site monitoring experience, preferably with oncology exposure.
• Prior global clinical trial experience and fluency in English plus the local language.
• Willingness to travel extensively (60‑80%) and hold a valid driver’s license and passport.

Required skills

• Advanced knowledge of ICH/GCP guidelines and FDA/local regulations.
• Expertise in clinical trial monitoring, data acquisition, cleaning and reporting.
• Experience supporting sponsor regulatory inspections and protocol feasibility assessments.
• Ability to work in a matrix environment and influence cross‑functional stakeholders.