Clinical Research Associate – Site Monitoring & Study Oversight

IQVIA; Ontario (CA); On-site; USD 7,100 - 189,000; Full time

Job summary

IQVIA is seeking a site-monitoring professional in the United States to ensure studies are conducted according to protocol, GCP, and sponsor requirements. The role encompasses on-site visits, site training, recruitment collaboration, and regulatory tracking.

Responsibilities include monitoring visits, recruitment planning, training, quality issue escalation, TMF/ISF maintenance, and cross-team collaboration to support project execution and site financial management when applicable.

Qualifications

• Bachelor's degree in a scientific discipline or health care field preferred.
• Minimum 2 years of on-site monitoring experience.
• Knowledge of Good Clinical Practice (GCP) and ICH guidelines.
• Proficiency with Microsoft Word, Excel and PowerPoint; familiarity with laptops and mobile devices.
• Excellent written and verbal English communication; strong organizational skills.
• Ability to manage time and budgets; build effective working relationships.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per contract scope and GCP.
• Coordinate subject recruitment plans with sites to improve predictability.
• Administer protocol training to sites and maintain open lines of communication.
• Assess site practices for protocol adherence; escalate quality issues as needed.
• Track regulatory submissions, approvals, recruitment, CRF completion, and data queries; support start-up if needed.
• Maintain TMF and ISF documents in compliance with regulatory requirements.
• Document site management activities; prepare visit reports and follow-up communications.
• Collaborate with study team members to support project execution and site finance if applicable.

Skills

Bachelor's Degree

On-site monitoring experience

GCP/ICH knowledge

MS Word/Excel/PowerPoint

English communication

Time and financial management

Relationship building

Education

Bachelor's Degree in scientific discipline or health care

Job description

IQVIA is seeking a site-monitoring professional in the United States to ensure studies are conducted according to protocol, GCP, and sponsor requirements. The role encompasses on-site visits, site training, recruitment collaboration, and regulatory tracking.

Responsibilities include monitoring visits, recruitment planning, training, quality issue escalation, TMF/ISF maintenance, and cross-team collaboration to support project execution and site financial management when applicable.