Clinical Research Associate II

Added
1 day ago
Type
Full time
Salary
Salary not provided

Related skills

site monitoring ctms cdms ich-gcp sae reconciliation

📋 Description

  • Perform and coordinate assigned clinical monitoring activities in accordance with ICH-GCP
  • Conduct site visits, including pre-study site visits, site initiation visits, interim monitoring
  • Act as the primary site manager, maintaining effective communication and collaborative
  • Assess protocol compliance, regulatory adherence, patient safety, and data quality during
  • Prepare accurate and timely monitoring reports and other required clinical documentation.
  • Provide protocol, study, and related training to assigned clinical research sites and support

🎯 Requirements

  • Bachelor’s degree in a relevant scientific discipline or equivalent academic background.
  • At least 2 years of relevant clinical operations experience, including a minimum of 1 year of
  • Experience with global clinical trials is preferred, particularly within oncology or hematology.
  • Pharmaceutical or biotechnology industry experience is highly desirable.
  • Thorough understanding of clinical trial processes, ICH-GCP principles, and applicable regulatory
  • Experience conducting site monitoring visits and managing investigative sites.

🎁 Benefits

  • Full-time, remote position based in Brazil.
  • Opportunity to work on clinical trials with global scope.
  • Exposure to pharmaceutical and biotechnology clinical research, with focus on oncology and
  • Opportunity to take ownership of site management and clinical monitoring activities.
  • Mentoring and development opportunities through collaboration with experienced clinical research
  • Opportunity to support and mentor less experienced CRAs.
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