Clinical Research Associate Jr
Merck Sharp & Dohme Corp.
Benito Juárez, MX
hace 5 días

Clinical Research Associate Jr Job

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Clinical Research Associate I

  • Acts as primary site contact and site manager for all operational and routine protocol issues in support of clinical research studies.
  • Communicates with sites on issues related to protocol conduct, enrollment / retention, protocol deviations, regulatory documentation, site audits / inspections, overall site performance, and financial payments.

  • Performs on-site monitoring visits, ensuring site compliance with protocol, ICH, GCP, Merck global standards, local laws and regulations, including but not limited to review of informed consent, AE / SAEs, Health Authority documentation, and IMP supplies.
  • Performs source document verification of subject data and query resolution.

  • Provides input to Site Selection utilizing site evaluation and validation processes.
  • Maintains accurate study site information in the CTMS and records visit and non-visit contacts appropriately and in a timely manner.
  • Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.

  • Manages less than a full complement of sites with multiple protocols,depending on study / site complexity. Discusses the need for escalation of site performance issues with CRM.
  • Qualifications

    2-4 years of Experience : 1-2 years clinical research preferred experience

    B.A. / B.S. preferred with strong emphasis in science

    Mi Correo Electrónico
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    Formulario de postulación