Clinical Research Associate — Site Monitoring Pro

IQVIA

Escondido (CA)

On-site

USD 75,000 - 198,000

Full time

14 days+

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Job summary

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring across multiple sites, ensuring protocol adherence and data integrity. You will coordinate with sites, manage training, and ensure proper documentation in the TMF as part of a regulated clinical trial environment.

The role requires a Bachelor’s degree in a scientific field and at least 2 years of CRA experience, with strong knowledge of GCP/ICH guidelines and systems like EDC/CTMS/eTMF.

Qualifications

  • Bachelor's Degree in scientific discipline or health care preferred.
  • At least 2 years on-site monitoring experience as a Clinical Research Associate.
  • Good knowledge of GCP/ICH guidelines.
  • Experience using EDC, CTMS, eTMF and related systems.
  • Strong communication and organizational skills.

Responsibilities

  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits).
  • Work with sites to drive subject recruitment plans.
  • Administer protocol training and maintain regular communication with sites.
  • Evaluate quality and integrity of site practices and escalate issues.
  • Track regulatory submissions, enrollment, CRF completion and data queries; support start-up as needed.
  • Maintain TMF/ISF documentation and site files.
  • Create and maintain monitoring reports and follow-up letters.
  • Collaborate with study team members for project execution.
  • May support site recruitment planning per site.
  • May oversee site financial management per project requirements.

Skills

Bachelor's Degree in scientific field
2+ years CRA on-site monitoring
GCP/ICH knowledge
MS Word/Excel/PowerPoint
EDC/CTMS/eTMF/IVRS-IWRS experience

Education

Bachelor's Degree in scientific discipline or health care

Tools

EDC
CTMS
eTMF
IVRS/IWRS
MS Word
Excel
PowerPoint

Job description

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring across multiple sites, ensuring protocol adherence and data integrity. You will coordinate with sites, manage training, and ensure proper documentation in the TMF as part of a regulated clinical trial environment.

The role requires a Bachelor’s degree in a scientific field and at least 2 years of CRA experience, with strong knowledge of GCP/ICH guidelines and systems like EDC/CTMS/eTMF.

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