Clinical Research Associate: Site Monitoring & Growth

MSD

Guaynabo (PR)

Hybrid

USD 90,000 - 120,000

Full time

5 days ago

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Job summary

MSD is seeking a Clinical Research Associate to manage assigned country sites and ensure study conduct aligns with ICH-GCP, local regulations, and Sponsor SOPs. You will serve as the primary site contact, expand the site network, and collaborate with cross-functional teams to maintain trial quality.

The role requires 5+ years in healthcare/site management, fluent English and local language skills, and the ability to travel up to 75% of the time.

Qualifications

Associate's degree or higher in healthcare or a related field.
Minimum 5 years of relevant healthcare/site management experience, including monitoring.

Responsibilities

Develops and maintains strong site relationships across all trial phases.
Performs site management/monitoring in line with ICH-GCP, Sponsor SOPs, local laws and regulations, and protocol.
Gains in-depth understanding of the study protocol and related procedures.
Coordinates tasks with sponsor roles to achieve Site Ready.
Participates in site selection and validation activities.
Conducts remote and on-site monitoring to ensure data accuracy and patient safety.
Documents visits and regulatory documentation thoroughly and timely.
Communicates with Investigators and site staff on protocol conduct, recruitment and regulatory issues.
Escalates site performance or compliance issues as needed in collaboration with CRA team.