Clinical Research Associate II

hace 2 días


Ecatepec de Morelos, México Syneos Health Clinical A tiempo completo
Job Summary

We are seeking a highly skilled Clinical Research Associate to join our team at Syneos Health Clinical. As a Clinical Research Associate, you will be responsible for performing site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.

Key Responsibilities
  • Perform site qualification, site initiation, interim monitoring, site management, and close-out visits to ensure regulatory, ICH-GCP, and protocol compliance.
  • Use judgment and experience to evaluate overall performance of site and site staff and provide recommendations regarding site-specific actions.
  • Maintain a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • Assess site processes, conduct source document review, and verify required clinical data entered in the case report form (CRF) is accurate and complete.
  • Apply query resolution techniques remotely and on site, and provide guidance to site staff as necessary.
  • Utilize available hardware and software to support the effective conduct of the clinical study data review and capture.
  • Verify site compliance with electronic data capture requirements and reconcile contents of the Investigator Site File (ISF) with the Trial Master File (TMF).
  • Understand project scope, budgets, and timelines for own and others' activities in the clinical team and manage site-level activities/communication to ensure project objectives, deliverables, and timelines are met.
  • May act as primary liaison with project site personnel and ensure all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
Requirements
  • Strong understanding of ICH/GCP Guidelines, relevant regulations, and company SOPs/processes.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and as part of a team.
  • Strong problem-solving and analytical skills.
  • Ability to adapt to changing priorities and deadlines.
What We Offer

We offer a competitive salary and benefits package, as well as opportunities for career growth and development. If you are a motivated and detail-oriented individual with a passion for clinical research, we encourage you to apply for this exciting opportunity.



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