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Clinical Research Coordinator

hace 2 meses

Xico, México Pharm-Olam International A tiempo completo
About Pharm-Olam International

Pharm-Olam International is a leading Contract Research Organization (CRO) with a global presence. We deliver cost-effective, quick-to-market clinical services in today's emerging marketplace.

Job Summary

We are seeking a highly organized and detail-oriented Clinical Trial Associate to join our team. As a Clinical Trial Associate, you will provide administrative support to our clinical study teams, ensuring the smooth conduct of international clinical studies.

Key Responsibilities
  • Assist CRAs, Lead CRAs, Clinical Team Leaders, and Project Managers with day-to-day administration of clinical studies.
  • Track critical documents and inform PM/CTL/LCRA of outstanding documents.
  • Accurately update and maintain clinical systems within project timelines.
  • Prepare, distribute, file, and archive clinical documentation.
  • Review study files periodically for accuracy and completeness.
  • Prepare and distribute clinical trial supplies and maintain tracking information.
  • Assist PM/CTL/LCRA/CRAs with collection and filing of critical documents.
  • Attend local Investigator and CRA meetings, record questions and answers, and coordinate with hotel staff.
  • May act as a central contact for clinical team for designated project communications, correspondence, and associated documentation.
  • Perform administrative tasks to support team members with clinical trial execution, as required.
  • Prepare Trial Master File according to Pharm-Olam SOPs with guidance of Project Manager and/or experienced CTAs, as required.
  • Assist with preparation of Investigator Site Files, Investigator Manuals, and Training Manuals with guidance of Project Manager, experienced CTAs, as required.
  • Assist with returning/archiving study files.
  • Communicate with sites regarding trial start-up, conduct, and close-out activities at requested intervals.
  • May participate in feasibility and/or site identification activities.
  • May attend clinical teleconferences and prepare and distribute minutes for Sponsor and Project Teams within agreed timelines.
About the Team

You will report to the Clinical Trial Associate Manager, COM or designee.