Senior Clinical Research Associate

Responsibilities

• Perform site monitoring visits including selection, initiation, monitoring, and close-out in accordance with GCP and ICH guidelines.
• Work with clinical sites to drive and track subject recruitment plans to meet project needs.
• Administer protocol-related training to assigned sites and maintain regular communication to manage project expectations.
• Evaluate the quality and integrity of study site practices and escalate quality issues as appropriate.
• Manage study progress by tracking regulatory submissions, enrollment, CRF completion, and data query resolution.
• Ensure site documents are properly filed in the Trial Master File (TMF) and the Investigator's Site File (ISF).
• Create and maintain documentation such as visit reports, follow-up letters, and action plans.
• Act as a mentor for clinical staff through co-monitoring and training visits.
• Support site financial management and invoice retrieval where applicable.

Requirements

• Bachelor's Degree in a scientific discipline or healthcare (preferred).
• At least 3 years of on-site monitoring experience.
• In-depth knowledge of GCP and ICH guidelines.
• Bilingual proficiency in both French and English.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Strong organizational, time management, and problem-solving skills.
• Ability to establish and maintain effective working relationships with colleagues and clients.

About the Company

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide.