Sr CRA or CRA II - sponsor dedicated - PORTUGAL
QuintilesIMS
Lisboa, Portugal
há 6 dias

Responsibilities

  • Perform site selection, initiation, monitoring and close-out visits and work with sites to adapt, drive and track subject recruitment plans.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations escalating quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (CRF) completion and submission, and data query generation and resolution.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans
  • Requirements

  • In depth knowledge and skill in applying applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
  • In depth therapeutic and protocol knowledge as provided in company training
  • Strong written and verbal communication skills including good command of English and Portuguese.
  • Excellent organizational and problem-solving skills
  • Effective time management skills
  • Bachelor's degree in a health care or other scientific discipline or educational equivalent
  • Mínimum 2 years of independent on-site monitoring experience
  • What we offer :

  • Working with one of the TOP 5 sponsors globally on international projects
  • Focus on quality, not quantity! We invest in keeping our teams stable, so workload is consistent
  • The chance to work on cutting edge medicines right at the forefront of drug development
  • Gnuine career development opportunities for those who want to grow as part of the organization
  • Excellent salary and benefits package
  • Flexible working hours
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