Site And Monitoring Health Lead / Lead Clinical Research Associate - Northeast Us - Fsp

Parexel

Northeast US
Significant direct monitoring experience with cro or pharma
Previous cro monitoring oversight experience required
Lead cra experience required
The Site and Monitoring Health Lead will apply knowledge of regulations and GCPs to safeguard the quality of clinical trial execution at investigator sites

Job Summary

  • The Site and Monitoring Health Lead will apply knowledge of regulations and GCPs to safeguard the quality of clinical trial execution at investigator sites.
  • Candidates must be located within one hour of a major airport in NY, NJ, MA, PA, ME, RI, NH, VT, CT, VA, MD, DE, or OH.
  • This role requires creating Study Specific Oversight Plans, conducting Sponsor Oversight Visits, and troubleshooting problems impacting clinical site delivery.

Matching Summary

The Site and Monitoring Health Lead will apply knowledge of regulations and GCPs to safeguard the quality of clinical trial execution at investigator sites.

Skills & Requirements

Must-have

  • Significant direct monitoring experience with CRO or pharma
  • Previous CRO monitoring oversight experience required
  • Lead CRA experience required
  • Experience in all study phases Phase I-III
  • Ability to travel approximately 50%
  • Proficient in MS Office Suite Excel Word PowerPoint

Nice-to-have

  • Previous audit and regulatory inspection experience preferred
  • Fluent in multiple languages and cultural awareness preferred
  • Ability to think innovatively and initiate changes
  • Strong relationship building with key investigators
  • Root cause analysis skills for issue mitigation

Key Requirements

  • Lead CRA experience required
  • Previous CRO monitoring oversight experience required
  • Experience in all study phases Phase I-III
  • Ability to travel approximately 50%

Work Rights

Not specified

Tailored Resume

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