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Clinical Research Specialist

1 semana atrás

Lisboa, Lisboa, Portugal Iqvia Argentina Tempo inteiro

Job Overview
In the role of Clinical Research Specialist, you will be responsible for ensuring compliance with local and international regulations, standard operating procedures (SOPs), project requirements, and contractual guidelines for site activation activities.
This position requires strong communication skills to serve as a Single Point of Contact (SPOC) between investigative sites, Site Activation Managers, Project Management teams, and other departments as necessary.
The ideal candidate will have experience in clinical research, regulatory compliance, and quality control.

Key Responsibilities:

  • Perform start-up and site activation activities according to applicable regulations, SOPs, and work instructions.
  • Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases, and tracking tools with project-specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish, and agree on project planning and project timelines.
  • Ensure monitoring measures are in place and implement contingency plans as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.

Requirements:

  • Bachelor's Degree in life sciences or a related field and 3 years' clinical research or other relevant experience; or equivalent combination of education, training, and experience.
  • Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
  • Knowledge of applicable regulatory requirements, including local regulations, SOPs, and company Corporate Standards.
  • Understanding of regulated clinical trial environment and knowledge of drug development process.