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Clinical Research Associate

hace 2 meses

Xico, México Thermo Fisher Scientific A tiempo completo

About Thermo Fisher Scientific

We are a leading global biotechnology company that enables our customers to make the world healthier, cleaner and safer. Our mission is to accelerate the discovery, development and delivery of life-changing therapies.

Job Summary

We are seeking a highly motivated and detail-oriented Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for performing remote activities on assigned projects, providing support with site preparedness, logistical support to the monitoring process, and assisting with assigned tasks for site management and remote monitoring in accordance with SOPs and regulatory guidelines.

Key Responsibilities

  • Completes study and site management activities as defined in task matrix, and as applicable and directed for study assigned
  • Completes and documents study-specific training
  • Orients and trains on any company/study-specific systems
  • Provides in-house support during pre-study assessments and with pre-study assessment waivers, as agreed for project
  • Supports to customize Site ICF with site contact details, as needed
  • Performs remote review of EMR/EHR checklist and supports collection, as applicable assessments
  • Verifies document collection and RCR submission status; updates site EDL and verifies site information
  • Reviews patient facing materials and review translations, as directed
  • Supports site staff with the vendor related qualification process, where applicable
  • Provides support by ensuring system access is requested/granted and revoked for relevant site staff during pre-activation and subsequent course of the study
  • Provides support to follow-up on site staff training, as applicable
  • Coordinates and supports logistics for IM attendance, as directed
  • Support with maintenance of vendor trackers, as directed
  • Coordinates study/site supply management during pre-activation and subsequent course of the study
  • Supports Essential Document collection, review and updating in systems, as applicable
  • Follow up and supports on missing study vendor data like ECGs, lab samples, and e-diaries, as directed
  • Supports ongoing remote review of centralized monitoring tools, as directed
  • Supports Site payments processes by coordinating with various functional departments within organization and site
  • Supports system updates and reconciliations, as directed and follows-up on site invoices throughout the study period
  • Performs reconciliation tasks on assigned trials including but not limited to CRF and query status, deviations, SAEs and safety reports, as applicable
  • Verifies document collection status in company systems and drives action for missing/incomplete/expired documents and open document findings, as directed
  • May perform other assigned site management tasks, as directed by RCRA and as per Task Matrix
  • May perform a specific role profile for FSP opportunities according to Client requests
  • Maintains & completes administrative tasks such as expense reports and timesheets in a timely manner

Requirements

  • Bachelor's Degree in a life science

What We Offer

We offer a competitive salary, comprehensive benefits package, and opportunities for career advancement in a dynamic and growing company. If you are a motivated and detail-oriented individual who is passionate about clinical research, we encourage you to apply for this exciting opportunity.