CRA (Level I)

The CRA (Level I) at Thermo Fisher Scientific performs and coordinates clinical monitoring and site management for clinical trials conducted in Bangkok, Thailand. Responsibilities include conducting remote and on-site monitoring visits, assessing protocol and regulatory compliance, reviewing data accuracy, managing investigational product inventory, documenting observations, and maintaining communication with investigational sites. The role requires a bachelor's degree in a life sciences field and approximately 2 years of relevant clinical monitoring experience, along with knowledge of ICH-GCP, applicable regulations, and risk-based monitoring concepts. Travel is required extensively, generally 60–80% or higher.

Monitor investigator sites using a risk-based monitoring approach, applying root cause analysis and problem-solving

Ensure data accuracy through SDR, SDV, and CRF review via on-site and remote monitoring

Document monitoring observations in reports and letters, escalating deficiencies to clinical management

Initiate clinical trial sites and perform trial close-out activities, ensuring ICH-GCP compliance

Maintain CTMS and trial status tracking, and facilitate communication among sites, clients, and project teams

Bachelor's degree in a life sciences-related field

Approximately 2 years of clinical monitoring or related experience

Basic medical/therapeutic-area knowledge and understanding of medical terminology

Working knowledge of ICH-GCP and applicable regulations

Good English language, communication, organizational, and computer skills