Not specified; ranges influenced by location + lab...
Fully remote
5 years field-based cra experience
Veeva vault ctms and cdms proficiency
Knowledge of ich gcp fda iso regulations
This role involves serving as a Lead CRA providing expert oversight of complex clinical studies including site selection, initiation, monitoring, and close-out activities
Job Summary
This role involves serving as a Lead CRA providing expert oversight of complex clinical studies including site selection, initiation, monitoring, and close-out activities.
The position requires maintaining complete, accurate, and audit-ready regulatory documentation and TMFs in accordance with ALCOA principles while ensuring patient safety.
Candidates will provide mentoring and functional oversight to CRAs, manage contingent staff, and collaborate cross-functionally with internal teams and CROs to ensure high-quality study execution.
Matching Summary
This role involves serving as a Lead CRA providing expert oversight of complex clinical studies including site selection, initiation, monitoring, and close-out activities.
Salary
Not specified; ranges influenced by location and labor laws
Skills & Requirements
Must-have
5 years field-based CRA experience
Veeva Vault CTMS and CDMS proficiency
Knowledge of ICH GCP FDA ISO regulations
Bachelor's degree in healthcare or science
Experience with multiple clinical trial phases
Nice-to-have
Laboratory experience in molecular biology
Experience with IVD and POC studies
Strong presentation and communication skills
Ability to work independently in fast-paced environment