Principal Clinical Research Associate

Waters Corporation

Sparks, MD, USA
Not specified; ranges influenced by labor laws + c...
Fully remote
5+ years field-based cra experience
Veeva vault ctms and cdms proficiency
Knowledge of ich gcp fda iso regulations
This role serves as a Lead CRA providing expert oversight of complex clinical studies including site selection, initiation, monitoring, and close-out activities

Job Summary

  • This role serves as a Lead CRA providing expert oversight of complex clinical studies including site selection, initiation, monitoring, and close-out activities.
  • The successful candidate will ensure strict compliance with regulatory requirements such as ICH GCP, FDA CFR, and ISO while maintaining audit-ready documentation.
  • Waters Corporation offers a culture of relentless innovation where associates partner with customers to turn scientific challenges into breakthroughs that improve lives worldwide.

Matching Summary

This role serves as a Lead CRA providing expert oversight of complex clinical studies including site selection, initiation, monitoring, and close-out activities.

Salary

Not specified; ranges influenced by labor laws and CBA requirements applicable to the work location

Skills & Requirements

Must-have

  • 5+ years field-based CRA experience
  • Veeva Vault CTMS and CDMS proficiency
  • Knowledge of ICH GCP FDA ISO regulations
  • Experience with medical device or pharma studies
  • Ability to author and approve Monitoring Plans

Nice-to-have

  • Laboratory experience in molecular biology
  • Experience with IVD and POC studies
  • Strong presentation and communication skills
  • Mentoring contingent CRA staff
  • Technically savvy for efficiency drive

Key Requirements

  • Bachelor's degree in healthcare or science field
  • Minimum 5 years of field-based CRA experience
  • Proficiency with Veeva Vault CTMS and CDMS required

Work Rights

Not specified

Tailored Resume

Cover Letter