Clinical Research Associate - Site Monitoring Pro

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

Job summary

IQVIA is seeking a Clinical Research Associate to monitor study sites and ensure data integrity in line with the protocol, GCP, and sponsor requirements.

Responsibilities include site visits, recruitment tracking, protocol training, and maintaining TMF/ISF documentation while collaborating with the study team. A BA/BS in a scientific field and 2+ years on-site CRA experience are preferred.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• 2+ years of independent on-site CRA monitoring experience required.
• Knowledge of GCP and ICH guidelines.
• English language proficiency; strong communication skills.
• Proficiency with MS Word, Excel and PowerPoint; device usage as applicable.

Responsibilities

• Perform site monitoring visits in accordance with scope of work and GCP.
• Drive subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol training to sites and maintain regular communication.
• Evaluate site practices for protocol conduct and regulatory adherence; escalate issues.
• Track submissions, recruitment, CRF completion, data queries; may support start-up.
• Ensure TMF/ISF filing and regulatory document maintenance.
• Create and maintain documentation of site management and visit findings.
• Collaborate with study team for project execution and site support.

Skills

GCP/ICH knowledge

English proficiency

Communication skills

Organizational skills

Time management

Education

Bachelor's Degree in scientific discipline or health care

Tools

EDC systems

CTMS

eTMF

IVRS/IWRS

MS Office (Word/Excel/PowerPoint)

Job description

IQVIA is seeking a Clinical Research Associate to monitor study sites and ensure data integrity in line with the protocol, GCP, and sponsor requirements.

Responsibilities include site visits, recruitment tracking, protocol training, and maintaining TMF/ISF documentation while collaborating with the study team. A BA/BS in a scientific field and 2+ years on-site CRA experience are preferred.