Senior Cardiovascular CRA Remote Site Leadership

Merck; Rahway (NJ); Remote; USD 129,000 - 203,000; Full time

Job summary

Merck in Rahway, NJ seeks an experienced Clinical Research Associate (CRA) responsible for performance and compliance of study conduct across sites, ensuring ICH/GCP adherence and country regulations. Primary site contact and site manager across all trial phases, with travel to domestic and international sites.

Responsibilities include developing site relationships, monitoring activities (remote and on-site), regulatory documentation, and mentoring junior CRAs.

Qualifications

• Fluent Spanish speaking skills required.
• Associate’s degree, certificate or equivalent in a scientific / healthcare discipline together with at least 7 years of relevant experience in the healthcare field, including at least 4 years of direct site management (monitoring) experience in bio / pharma / CRO.
• Bachelor’s degree (or above) with at least 4 years of direct site management (monitoring) experience in a bio / pharma / CRO.

Responsibilities

• Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
• Performs clinical study site management/monitoring activities in compliance with ICH-GCP, Sponsor SOPs, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
• Gains an in-depth understanding of the study protocol and related procedures.
• Coordinates & manages various tasks in collaboration with other sponsor roles to achieve Site Ready.
• Performs remote and on-site monitoring & oversight activities using various tools to ensure: Data generated at site are complete, accurate and unbiased.
• Mentors / buddies junior CRAs on process/study requirements and performs co-monitoring visits where appropriate.

Skills

Site Management

Monitoring

Regulatory Documentation

ICH-GCP Compliance

Clinical Research Knowledge

Education

Bachelor’s degree or higher in relevant field

Associate’s degree or equivalent in scientific/healthcare discipline

Job description

Merck in Rahway, NJ seeks an experienced Clinical Research Associate (CRA) responsible for performance and compliance of study conduct across sites, ensuring ICH/GCP adherence and country regulations. Primary site contact and site manager across all trial phases, with travel to domestic and international sites.

Responsibilities include developing site relationships, monitoring activities (remote and on-site), regulatory documentation, and mentoring junior CRAs.