Junior CRA: Site Monitoring & Study Coordinator

Merck

Buenos Aires

On-site

ARS 1,000,000 - 1,400,000

Full time

10 days ago

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Job summary

Merck is seeking an experienced Clinical Research Associate to act as the primary site contact and site manager across all trial phases. You will build strong site relationships, perform on-site monitoring, and ensure regulatory documentation aligns with ICH-GCP and Sponsor SOPs.

You will collaborate with CRA teams and other sponsor functions to achieve Site Ready, participate in site selection, and manage visits and reports in CTMS/eTMF, supporting audits as needed.

Qualifications

  • BS/BA in science or related field; clinical research exposure.
  • Minimum 2 years of clinical research experience.
  • Experience with regulatory documentation and site management.

Responsibilities

  • Act as primary site contact and site manager through all trial phases.
  • Develop and maintain strong site relationships for continuity.
  • Perform site management/monitoring per ICH-GCP and sponsor SOPs.
  • Coordinate tasks with sponsor roles to achieve Site Ready.
  • Conduct site visits (validation, initiation, monitoring, close-out) and prepare reports.
  • Collect and monitor regulatory documents for start-up, maintenance, and close-out.
  • Communicate with investigators on protocol conduct, recruitment, and deviations.
  • Identify and resolve site performance or compliance issues with escalation as needed.
  • Collaborate with country operations, regulatory, pharmacovigilance, and external partners.
  • Maintain documentation in CTMS/eTMF and other systems; support audits/inspections.
  • Possibly perform co-monitoring when appropriate.

Skills

Site management
On-site monitoring
ICH-GCP
Regulatory compliance
Data analysis
Communication skills
Problem solving

Education

B.A./B.S. in science

Tools

CTMS
eTMF
MS Office

Job description

Merck is seeking an experienced Clinical Research Associate to act as the primary site contact and site manager across all trial phases. You will build strong site relationships, perform on-site monitoring, and ensure regulatory documentation aligns with ICH-GCP and Sponsor SOPs.

You will collaborate with CRA teams and other sponsor functions to achieve Site Ready, participate in site selection, and manage visits and reports in CTMS/eTMF, supporting audits as needed.

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