Clinical Research Associate II (CRA II)

About the role

Thermo Fisher Scientific is seeking a Clinical Research Associate II to independently manage assigned clinical trial sites. You will ensure studies follow protocols, ICH‑GCP guidelines, local regulations, and sponsor requirements while supporting innovative therapies worldwide.

Key responsibilities

• Conduct site qualification, initiation, routine monitoring, and close‑out visits, both on‑site and remotely.
• Verify subject safety, protocol compliance, data quality, and source documentation.
• Review case report forms, source documents, and investigational product accountability.
• Identify site risks, perform root‑cause analysis, and implement corrective actions.
• Prepare accurate monitoring reports, follow‑up letters, and maintain essential study documentation.
• Maintain communication with investigators, site personnel, sponsors, and internal project teams.
• Track study progress in clinical trial management systems (CTMS) and support audit/inspection readiness.
• Participate in investigator meetings, training activities, and contribute to process improvements.

Required profile

• Bachelor’s degree in Life Sciences, Pharmacy, Nursing, Medicine, or a related healthcare discipline.
• At least one year of independent clinical monitoring experience as a CRA or successful completion of the PPD Drug Development Fellowship.
• Strong understanding of ICH‑GCP guidelines and applicable regulatory requirements.

Required skills

What we offer

• Opportunity to work within a global, collaborative team on high‑impact clinical trials.
• Access to professional development and training resources.