Clinical Research Associate - On-Site Monitoring Expert

IQVIA; O'Fallon (IL); Sur place; USD 75 000 - 198 000; Plein temps

Résumé du poste

IQVIA is seeking a Clinical Research Associate to join our global clinical operations team. The role involves performing site monitoring visits, ensuring data quality and regulatory compliance across trials, and supporting site performance with training and communication.

You will manage site relationships, track recruitment and data flow, and help maintain documentation in the TMF. A Bachelor’s degree and 2+ years on-site CRA experience are preferred.

Qualifications

• Requires a Bachelor's Degree in scientific discipline or health care.
• At least 2 years of independent on-site CRA experience.
• Equivalent combination of education, training and experience accepted.
• Good knowledge of clinical research regulatory requirements (GCP/ICH).
• Experience with EDC, CTMS, eTMF, IVRS/IWRS and other systems.
• Excellent verbal and written English communication.
• Strong time, financial and relationship-management skills.

Responsabilités

• Perform site monitoring visits (selection, initiation, monitoring, close-out) per SOW and GCP.
• Collaborate with sites to recruit subjects per project needs.
• Administer protocol training and maintain site communications.
• Evaluate site practices for protocol conduct and regulatory compliance.
• Track regulatory submissions, approvals, recruitment, CRF completion and data queries.
• Maintain TMF and ISF documentation per regulatory requirements.

Connaissances

On-site monitoring

GCP/ICH knowledge

Communication skills

Organizational skills

Time management

Formation

Bachelor's degree in scientific discipline or health care

Outils

EDC

CTMS

eTMF

IVRS/IWRS

MS Office

Description du poste

IQVIA is seeking a Clinical Research Associate to join our global clinical operations team. The role involves performing site monitoring visits, ensuring data quality and regulatory compliance across trials, and supporting site performance with training and communication.

You will manage site relationships, track recruitment and data flow, and help maintain documentation in the TMF. A Bachelor’s degree and 2+ years on-site CRA experience are preferred.