Senior Cardiovascular CRA — Site Leader

Merck & Co.; United States; Remoto; USD 129.000 - 203.000; Tempo pieno

Descrizione del lavoro

Merck & Co. in the United States is seeking a Clinical Research Associate (CRA) with strong site management experience to oversee performance and compliance for assigned protocols and sites, ensuring ICH/GCP and country regulations are met across all trial activities.

The role requires traveling 65-75% of time, building site relationships, monitoring visits, regulatory documentation, and collaboration with cross-functional teams.

Competenze

• Associate/bachelor degree required with significant site monitoring experience.
• Fluent Spanish required; demonstrates strong regulatory and documentation skills.
• Strong knowledge of ICH-GCP, regulatory inspections, and site management practices.

Mansioni

• Develops strong site relationships and maintains continuity through all trial phases.
• Performs site management/monitoring per ICH-GCP, Sponsor SOPs, local laws, and protocol.
• Gains understanding of protocol and collaborates with sponsor roles to achieve Site Ready.

Conoscenze

Site management

Monitoring

ICH-GCP

Regulatory compliance

Data integrity

Spanish language

Documentation

Formazione

Bachelor's degree + 4+ years site monitoring

Associate's degree + 7+ years healthcare experience

Strumenti

CTMS

eTMF

MS Office

Descrizione del lavoro

Merck & Co. in the United States is seeking a Clinical Research Associate (CRA) with strong site management experience to oversee performance and compliance for assigned protocols and sites, ensuring ICH/GCP and country regulations are met across all trial activities.

The role requires traveling 65-75% of time, building site relationships, monitoring visits, regulatory documentation, and collaboration with cross-functional teams.