Clinical Research Associate: Sponsor‑Dedicated Site Manager

IQVIA

Gloucester (VA)

On-site

USD 72,000 - 189,000

Full time

29 hours ago
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Job summary

IQVIA in the United States seeks a Site Monitor to ensure study sites perform per protocol and report data per sponsor requirements, while maintaining GCP/ICH standards.

You will conduct monitoring visits, support subject recruitment, manage site communications, and track submissions, CRF completion, and data queries, maintaining TMF/ISF documentation and collaborating with study teams.

Qualifications

  • At least 2 years of on-site monitoring experience.
  • Knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Knowledge of clinical research regulatory requirements.
  • Proficiency in Word, Excel and PowerPoint; familiarity with laptop and mobile devices.

Responsibilities

  • Perform site monitoring visits per scope of work and GCP.
  • Collaborate with sites to drive subject recruitment in line with project needs.
  • Administer protocol training and maintain regular site communication.
  • Evaluate site practices for protocol adherence and regulatory compliance.
  • Track regulatory submissions, recruitment, CRF completion, data queries; may support start-up.
  • Maintain TMF/ISF documents and prepare visit reports and follow-up letters.
  • Coordinate with study team for project execution support.
  • Support development of site recruitment plans and site financial management if applicable.

Skills

On-site monitoring
English communication
Time management
Regulatory knowledge

Education

Bachelor's Degree in scientific discipline

Tools

Microsoft Word
Microsoft Excel
PowerPoint
iPhone/iPad

Job description

IQVIA in the United States seeks a Site Monitor to ensure study sites perform per protocol and report data per sponsor requirements, while maintaining GCP/ICH standards.

You will conduct monitoring visits, support subject recruitment, manage site communications, and track submissions, CRF completion, and data queries, maintaining TMF/ISF documentation and collaborating with study teams.

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