Clinical Research Associate: Site Monitoring Expert

IQVIA; Northfield (MN); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to perform site monitoring and management to ensure study sites conduct and report data per protocol and guidelines. You will work to recruit subjects, administer training, and track regulatory submissions with regular communication to sites.

Ideal candidates have 2+ years of on-site CRA experience, strong GCP/ICH knowledge, and proficiency with EDC/CTMS/eTMF. Excellent English communication and organizational skills are essential.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• Requires at least 2 years of independent on-site monitoring experience as a CRA in a CRO, sponsor, or similar setting.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of, and skill in applying, clinical research regulatory requirements (GCP & ICH).
• Proficiency in Microsoft Word, Excel and PowerPoint and use of a laptop and mobile devices.
• Experience utilizing EDC, CTMS, eTMF, IVRS/IWRS and other clinical trial systems.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Drive subject recruitment plans to enhance project predictability.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, data queries; support start-up as needed.
• Maintain TMF and ISF documentation in line with regulatory requirements.
• Prepare visit reports and follow-up letters; support project execution with the team.

Skills

Written and verbal communication

Time management

Organizational skills

Problem solving

Team collaboration

Attention to detail

Education

Bachelor's Degree in scientific discipline or health care preferred

Tools

Microsoft Word

Excel

PowerPoint

EDC

CTMS

eTMF

IVRS/IWRS

Job description

IQVIA is seeking a Clinical Research Associate to perform site monitoring and management to ensure study sites conduct and report data per protocol and guidelines. You will work to recruit subjects, administer training, and track regulatory submissions with regular communication to sites.

Ideal candidates have 2+ years of on-site CRA experience, strong GCP/ICH knowledge, and proficiency with EDC/CTMS/eTMF. Excellent English communication and organizational skills are essential.