Clinical Research Professional

Há 2 dias

São Paulo, São Paulo, Brasil beBeeOncology Tempo inteiro US$110.520 - US$138.150
Role Overview

We are seeking a Senior Clinical Research Associate (CRA) to join our team. As a key member of our clinical research organization, you will be responsible for supporting Oncology site success and maintaining a continuous state of inspection readiness.

Key Responsibilities:
  • Perform site management activities to ensure Oncology site success and maintain a continuous state of inspection readiness.
  • Act as the primary contact and facilitate efficient communications between the clinical trial team and the sites.
  • Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in trials.
  • May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs.
  • Promptly document monitoring activities and submit/approve visit reports.
  • Manage site essential document collection and TMF reconciliation with site files.
  • Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals.
  • Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution.
  • Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans.
  • Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations.
  • Support sites during regulatory inspections.
  • Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities.
  • Lead site engagement initiatives and foster relationships with key Oncology sites and networks.
Requirements:
  • Bachelor's degree (scientific field preferred).
  • 5+ years monitoring Oncology trials independently conducting on-site and remote monitoring visits.
  • 1+ years early development trial experience.
  • Solid tumor clinical trial experience is preferred.
  • Experience utilizing Veeva systems is preferred.
  • Demonstrated experience developing/maintaining site relationships and securing compliance.
  • Expertise in GCPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology.
  • Experience collaborating with sites from initial engagement through close-out phases.
  • Experience activating sites.
  • Experience training site staff.
  • Experience supporting sites and/or sponsors in regulatory inspections.
  • Experience working within an FSP (or in-house) monitoring model is preferred.
  • Willing to travel up to 50% domestically.
  • Reside in Midwest USA.
What We Offer:
  • A competitive salary and benefits package.
  • A range of annual leave entitlements.
  • A range of health insurance offerings to suit you and your family's needs.
  • Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
  • Global Employee Assistance Programme, offering 24-hour access to a global network of professionals who are there to support you and your family's well-being.
  • Life assurance.
  • Flexible country-specific optional benefits.

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