Clinical Research Monitor – Site Oversight & Data Quality

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

Job summary

IQVIA, a global leader in clinical research services, is seeking an experienced Clinical Research Associate to monitor trials and manage site activities. You will conduct monitoring visits, assist in recruitment planning, and ensure data integrity in line with the protocol and regulatory requirements.

The role requires 2+ years of CRA experience, strong regulatory knowledge, and proficiency with EDC/CTMS/eTMF systems.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• At least 2 years of independent on-site monitoring experience as a CRA.
• Experience with GCP and ICH guidelines.
• Proficient in Microsoft Word, Excel and PowerPoint; laptop and mobile devices.
• Experience using EDC, CTMS, eTMF, IVRS/IWRS in monitoring activities.

Responsibilities

• Perform site monitoring visits per scope of work and GCP.
• Drive subject recruitment plans to enhance predictability.
• Administer protocol training and maintain site communications.
• Evaluate site practices for protocol and regulatory adherence.
• Track regulatory submissions, recruitment, CRF, and data queries.
• Maintain TMF and ISF documentation and generate visit reports.

Skills

On-site monitoring

Regulatory knowledge

English communication

Time and financial management

Study teams collaboration

Microsoft Office proficiency

Education

Bachelor's Degree in scientific discipline or health care

Tools

EDC systems

CTMS

eTMF

IVRS/IWRS

MS Word/Excel/PowerPoint

Job description

IQVIA, a global leader in clinical research services, is seeking an experienced Clinical Research Associate to monitor trials and manage site activities. You will conduct monitoring visits, assist in recruitment planning, and ensure data integrity in line with the protocol and regulatory requirements.

The role requires 2+ years of CRA experience, strong regulatory knowledge, and proficiency with EDC/CTMS/eTMF systems.