Global Clinical Trials Professional

1 semana atrás

Brasil beBeeClinicalResearch Tempo inteiro R$90.000 - R$120.000
Job Overview

The Senior Clinical Research Associate I position is responsible for ensuring the quality and integrity of clinical trials. This involves site management, monitoring, and close-out of assigned investigator sites to ensure patient safety and compliance with Good Clinical Practices (GCP) and applicable prevailing laws.

The successful candidate will be accountable for site management and monitoring, managing investigator site relationships, and collaborating with the study team to achieve project goals, timelines, and quality deliverables.

  • Responsibilities:
  • Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and Sponsor standards.
  • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock.
  • Serve as the primary point of contact for assigned investigator sites and work in partnership with and/or escalate to the Site Care Partner to ensure quality of site delivery.
  • Interface with the study team as needed, facilitate information flow between members of the study team, vendors, and assigned investigator sites.
  • Partner with Site Care Partner to perform investigator site development, coaching, and training of site personnel to ensure ongoing compliance with protocol and safeguarding of patients.
  • Attend investigator meetings when required (virtual or F2F). Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.
  • Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring, and study site closure activities.
  • Monitor site level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports to resolution.
  • Submit all required reports, documentation, updates, and tracking within required timeframes.
  • Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and prevent recurrence/persistence of issues.
  • Resolve data queries within required timelines, prepare investigator site close-out plan, and conduct close-out activities within required timelines.
  • Ensure adequate oversight of the investigational product at the investigator site.

Requirements:

  • Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA), and local country regulations.
  • Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology).
  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
  • Must be fluent in English and in the native language(s) of the country they will work in.
  • Ability to travel 60-80%.
  • Valid driver's license and passport required.
  • Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background, or equivalent.

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