Clinical Research Associate: Site Monitoring & Study Delivery

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

Job summary

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring and site management to ensure study conduct and data reporting per protocol and regulations. You will monitor sites, manage recruitment plans, and ensure TMF/ISF accuracy, while collaborating with the study team.

Requirements include a Bachelor’s degree in a scientific discipline or healthcare and at least 2 years of on-site CRA experience. Proficiency with EDC/CTMS/eTMF and MS Office is expected.

Qualifications

• Bachelor's degree or higher in a scientific discipline or health care.
• At least 2 years of on-site monitoring experience as a CRA in CRO/sponsor or similar.
• Equivalent education/experience accepted.
• Knowledge of GCP and ICH guidelines.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per scope of work and GCP.
• Coordinate subject recruitment plans to improve predictability.
• Administer protocol training and maintain regular communication with sites.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues.
• Track regulatory submissions, recruitment, CRF completion, data queries; support start-up.
• Maintain TMF/ISF documentation; generate visit reports and follow-up letters.
• Collaborate with study team for project execution and site support.

Skills

On-site monitoring

Communication

Organizational skills

Time management

Problem-solving

Team collaboration

Education

Bachelor's degree in scientific discipline or health care

Tools

EDC

CTMS

eTMF

IVRS/IWRS

MS Word/Excel/PowerPoint

Job description

IQVIA is seeking a Clinical Research Associate to perform on-site monitoring and site management to ensure study conduct and data reporting per protocol and regulations. You will monitor sites, manage recruitment plans, and ensure TMF/ISF accuracy, while collaborating with the study team.

Requirements include a Bachelor’s degree in a scientific discipline or healthcare and at least 2 years of on-site CRA experience. Proficiency with EDC/CTMS/eTMF and MS Office is expected.