Senior CRA — Remote/Onsite Monitoring Expert

ThermoFisher Scientific; Chile; Remote; CLP 15,000,000 - 23,000,000; Full time

Benefits offered by this job

Healthcare

Incentive plan

Job summary

Thermo Fisher Scientific is seeking an experienced Clinical Monitoring professional to oversee site visits and regulatory compliance across trials. You will manage documentation, ensure data integrity, and coordinate with sponsors and the client team.

Qualified candidates will have a life sciences background, 5+ years in clinical monitoring, and strong knowledge of FDA guidelines and ICH-GCP. Travel is required and collaboration with global teams is essential.

Qualifications

• Bachelor's degree in a life science related field or equivalent and relevant formal academic qualification.
• Considerable clinical research monitoring experience (roughly 5+ years) with expertise in monitoring.
• Knowledge of FDA guidelines, ICH-GCP, regulations and procedural documents.

Responsibilities

• Monitors sites using a risk-based approach and ensures data accuracy through SDR, SDV, and CRF review.
• Provides trial status updates to Clinical Team Manager and maintains CTMS conventions.
• Participates in investigator meetings, initiates sites per procedures, and ensures regulatory compliance.
• Maintains essential documents per ICH-GCP and project specifications.
• Supports publication/tools and collaborates with project teams to improve processes.

Skills

Expert clinical monitoring

FDA guidelines knowledge

ICH GCPs familiarity

Regulatory knowledge

Strong written communication

Data review and documentation

Root cause analysis

Risk based monitoring

Microsoft Office proficiency

Education

Bachelor's degree in life sciences

Tools

CTMS

SDV/SDR familiarity

Job description

Thermo Fisher Scientific is seeking an experienced Clinical Monitoring professional to oversee site visits and regulatory compliance across trials. You will manage documentation, ensure data integrity, and coordinate with sponsors and the client team.

Qualified candidates will have a life sciences background, 5+ years in clinical monitoring, and strong knowledge of FDA guidelines and ICH-GCP. Travel is required and collaboration with global teams is essential.