Clinical Research Specialist

Insight Global

Irvine (CA)

On-site

USD 85,000 - 110,000

Full time

3 days ago
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Job summary

Insight Global in Irvine, CA is seeking a Clinical Research Specialist to support a long-term post-market clinical trial for breast implants. You will monitor clinical studies, verify data, ensure regulatory compliance, and manage study documentation while coordinating site visits and travel reports.

This role requires 2+ years in clinical research/monitoring, familiarity with sponsor companies or hospitals, and experience with Class III medical devices.

Qualifications

  • 2+ years as clinical research specialist/associate or field monitor from sponsor company or hospital.
  • 2+ years of experience working on a clinical trial.
  • Experience with Class III medical devices.

Responsibilities

  • Monitoring clinical studies and coordinating site visits.
  • Data verification and ensuring regulatory compliance.
  • Maintaining study documentation and travel reports.

Skills

Monitoring clinical studies
Data verification
Regulatory compliance
Study documentation

Education

Bachelor's degree

Job description

A large medical device company in Irvine, CA is looking for a Clinical Research Specialist. This candidate will play a crucial role in supporting a 10 year post market clinical trial for breast implants. Their key responsibilities will include monitoring clinical studies, data verification, regulatory compliance, study documentation, site visits and coordination, and developing written travel reports.

Required Skills & Experience
  • 2+ years of experience as a clinical research specialist/associate or field monitor coming from a background of a sponsor company (medical device / biotechnology / pharmaceutical company) , or a hospital
  • 2+ years of experience working on a clinical trial
  • Bachelor's Degree
  • Experience with Class III medical device
Nice to Have Skills & Experience
  • Experience co monitoring / co shadowing a CRO
  • Experience with vendor management
  • Experience with long term study retention of subjects
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