Senior CRA - Oncology

Senior Clinical Research Associate at Thermo Fisher Scientific responsible for independent monitoring of clinical trial sites in Chile, with expertise in oncology studies. Manages site selection, initiation, monitoring, and closure while ensuring compliance with ICH-GCP guidelines and regulatory requirements.

Responsibilities

Conduct site initiation, monitoring visits, and closure activities in compliance with procedural documents

Perform source data verification, case report form review, and source data review per monitoring plan

Manage study supplies, drug accountability, and serious adverse event reporting

Train site staff on study requirements and ensure completion of mandatory training documentation

Prepare monitoring visit reports and coordinate with Local Study Team and regulatory authorities

Requirements

Minimum 3-5 years of experience as a clinical research monitor

Specialized therapeutic expertise in oncology

Ability to work independently across all study phases

Valid driving license

Ability to travel internationally as required

Knowledge of ICH-GCP guidelines and regulatory compliance

Experience with CTMS systems and electronic Trial Master Files