Background

A mid-sized U.S.-based medical device manufacturer was preparing to initiate a clinical trial for a new Class II device. The company needed additional Clinical Research Associate (CRA) support to oversee trial sites, ensure protocol compliance, and meet regulatory expectations. With limited internal bandwidth and a fast-approaching study start date, the client turned to Assurea’s contract staffing division for a flexible solution.

Challenge

The client faced a specific challenge:

  • Time-Sensitive Trial Launch – The study required a CRA to be onboarded and trained within four weeks to meet the FDA-reviewed trial timeline.
  • Geographically Dispersed Sites in the U.S. – The trial included multiple investigator sites across several states, requiring a CRA comfortable with remote monitoring combined with selective on-site visits.
  • Compliance Risk – Delays or incomplete monitoring could have resulted in protocol deviations and potential regulatory setbacks.

Our Approach

Assurea deployed a targeted staffing solution:

  1. Rapid Candidate Search – Within two weeks, we identified and presented a highly experienced CRA with a track record in U.S. medical device trials.
  2. Hybrid Monitoring Readiness – The CRA was vetted for their ability to conduct both on-site visits and remote monitoring using the client’s electronic trial management system.
  3. Streamlined Onboarding – Assurea facilitated a fast-track onboarding process, integrating the CRA into the client’s SOPs, reporting cadence, and study protocols in under two weeks.
  4. Ongoing Support – We maintained project update meetings and close communication with both the client and the CRA, ensuring continued alignment and performance monitoring throughout the engagement.

Results

The staffing solution delivered measurable results:

  • Trial Launched on Schedule – The CRA was fully onboarded within four weeks, allowing the study to begin without delays.
  • Compliance Maintained – Monitoring reports were submitted on time, with no critical findings during internal audits.
  • Operational Flexibility – The client was able to extend the CRA’s contract beyond the initial trial phase, ensuring continuity without long-term commitments.

Conclusion

Through Assurea’s contract staffing expertise, the medical device manufacturer successfully filled a critical CRA role in time for trial initiation. By providing a vetted, hybrid-ready contractor, Assurea helped the client maintain compliance, meet regulatory deadlines, and manage costs — demonstrating how our contract staffing solutions for life sciences provide the agility needed to keep trials on track.