Clinical Research Associate: Site Monitoring & Trial Delivery

IQVIA; Berkeley (CA); On-site; USD 75,000 - 198,000; Full time

Job summary

IQVIA is seeking an on-site Clinical Research Associate in Berkeley to monitor studies and ensure data integrity and regulatory compliance. You will partner with sites to drive recruitment, manage protocol training, and maintain essential study documents.

The role requires 2+ years as CRA in CRO/sponsor settings, strong knowledge of GCP/ICH, and proficiency with EDC, CTMS, and eTMF systems; English communication must be excellent.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• 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.
• Good knowledge of GCP and ICH guidelines.
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including Word, Excel and PowerPoint; laptop and mobile devices.
• Experience utilizing EDC, CTMS, eTMF, IVRS/IWRS and other trial systems.
• Excellent written and verbal English communication; strong organizational and problem-solving skills.

Responsibilities

• Perform monitoring visits (selection, initiation, monitoring, close-out) per scope and GCP.
• Collaborate with sites to recruit subjects per project needs.
• Administer protocol training to sites and maintain regular communication.
• Assess site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, approvals, recruitment, CRF completion, and data queries.
• Ensure TMF and ISF documentation is complete and accurate.
• Create visit reports and follow-up letters; support study documentation.
• Coordinate with study team for project execution and issue resolution.
• May support start-up activities and site financial management where applicable.

Skills

On-site monitoring experience

CRA experience

GCP & ICH knowledge

EDC/CTMS/eTMF systems

English communication

Regulatory knowledge

Microsoft Word/Excel/PowerPoint

Time & financial management

Education

Bachelor's Degree in scientific discipline or health care

Tools

EDC

CTMS

eTMF

IVRS/IWRS

Microsoft Word

Excel

PowerPoint

Job description

IQVIA is seeking an on-site Clinical Research Associate in Berkeley to monitor studies and ensure data integrity and regulatory compliance. You will partner with sites to drive recruitment, manage protocol training, and maintain essential study documents.

The role requires 2+ years as CRA in CRO/sponsor settings, strong knowledge of GCP/ICH, and proficiency with EDC, CTMS, and eTMF systems; English communication must be excellent.