Clinical Research Associate: Site Monitoring Expert

IQVIA; West Point (VA); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to monitor study sites and ensure compliant conduct of the protocol in line with GCP and ICH guidelines. The role involves initiating and monitoring visits, coordinating with sites for recruitment plans, and maintaining study documentation across TMF/ISF records.

Ideal candidates will have a Bachelor’s degree in a scientific field or health care, 2+ years of on-site CRA experience, and proficiency with EDC/CTMS/eTMF.

Qualifications

• Bachelor's Degree in scientific discipline or healthcare preferred.
• At least 2 years of independent on-site monitoring experience as a CRA in CRO/sponsor or similar setting.
• Knowledge of GCP and ICH guidelines.
• Proficiency with MS Word, Excel and PowerPoint; comfortable with laptops and mobile devices.
• Experience using EDC, CTMS, eTMF, IVRS/IWRS and other clinical trial systems.

Responsibilities

• Perform site monitoring visits (initiation, monitoring, close-out) per scope of work and GCP.
• Collaborate with sites to recruit and manage subject enrollment to meet project needs.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site adherence to protocol and regulatory requirements; escalate issues as needed.
• Track regulatory submissions, approvals, recruitment, data capture, and query resolution; support start-up as needed.
• Maintain TMF/ISF documentation per regulatory requirements.
• Prepare visit reports and follow-up correspondence.
• Coordinate with study team for project execution and site-level planning.
• Support development of site recruitment plans and, if applicable, site finances.

Skills

Regulatory knowledge

GCP/ICH familiarity

English communication

Organizational skills

Time/money management

Relationship building

Education

Bachelor's degree in scientific field or healthcare

Equivalent combination of education and experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

EDC

CTMS

eTMF

IVRS/IWRS

Job description

IQVIA is seeking a Clinical Research Associate to monitor study sites and ensure compliant conduct of the protocol in line with GCP and ICH guidelines. The role involves initiating and monitoring visits, coordinating with sites for recruitment plans, and maintaining study documentation across TMF/ISF records.

Ideal candidates will have a Bachelor’s degree in a scientific field or health care, 2+ years of on-site CRA experience, and proficiency with EDC/CTMS/eTMF.