FSP CRA II

Thermo Fisher Scientific is hiring an FSP Clinical Research Associate II based in Bangkok, Thailand, supporting GSK-sponsored studies. The role involves performing site evaluation, initiation, monitoring, and close-out visits, ensuring adherence to ICH-GCP, protocol, and GSK standards, and maintaining study documentation in the eTMF. The CRA will manage site relationships, drive subject recruitment and retention, conduct risk-based monitoring using GSK's RBQM tools, and ensure timely data entry, query resolution, and safety reporting. Candidates need strong communication, organizational, and problem-solving skills, knowledge of local regulations and ICH-GCP guidelines, and the ability to travel and work independently in a remote team environment.

Performs operational site evaluation, initiation, on-site/off-site monitoring, and close-out visits at the required frequency

Determines study protocol feasibility, including staff availability, clinical facilities, and patient population suitability

Conducts monitoring visits per the Trial Monitoring Plan using GSK's RBQM systems/tools to assess site risk

Ensures timely data entry, query resolution, source document review (ALCOAC+), and eTMF filing

Maintains site relationships, drives subject recruitment and retention, and ensures inspection readiness and compliance with ICH-GCP

Strong written and verbal communication skills in English and local language, with good presentation and negotiation abilities

Self-starter able to work within remote teams and independently, managing multiple priorities of increasing scope and complexity

Knowledge of local regulations and IND/ICH GCP guidelines

Proficient in Risk Based Quality Management (RBQM) and comfortable using GSK's RBQM systems/tools

Willing and able to travel as required, with strong computer skills and attention to detail