Senior Cardiovascular CRA — Remote, High-Impact Site Leadership

Merck

Montgomery (AL)

À distance

USD 129 000 - 203 000

Plein temps

Il y a 2 jours
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Avantages offerts par ce poste

Medical, dental, vision insurance
401(k) retirement plan
Paid holidays

Résumé du poste

Merck & Co., Inc. in Rahway, NJ is seeking an experienced Clinical Research Associate to manage site performance and monitoring across multiple trials, ensuring compliance with ICH-GCP and applicable regulations.

You will act as primary site contact and oversee monitoring activities from initiation through close-out. The role involves developing site relationships, coordinating with sponsor teams, and ensuring data integrity and patient safety.

Qualifications

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

Responsabilités

  • 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 related documents.
  • Gains an in-depth understanding of the study protocol and related procedures.
  • Coordinates and manages tasks with other sponsor roles to achieve Site Ready.
  • Participates in site selection and validation activities.
  • Performs remote and on-site monitoring and oversight to ensure accurate data and patient safety.

Connaissances

Site management
Monitoring
ICH-GCP
Data management
Regulatory knowledge
Cross-functional collaboration
Problem solving
Time management

Formation

Associate's degree in scientific/healthcare
Bachelor's degree in science/healthcare

Outils

CTMS
eTMF

Description du poste

Merck & Co., Inc. in Rahway, NJ is seeking an experienced Clinical Research Associate to manage site performance and monitoring across multiple trials, ensuring compliance with ICH-GCP and applicable regulations.

You will act as primary site contact and oversee monitoring activities from initiation through close-out. The role involves developing site relationships, coordinating with sponsor teams, and ensuring data integrity and patient safety.

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