Associé de recherche clinique – Francophone – IQVIA Clinical Research Associate – French speaking

Associé de recherche clinique – Francophone – IQVIA Clinical Research Associate – French speaking

Requirements

• 3 years of experience in follow-up
• BS/BA/BSc (or equivalent) in one of the life sciences or healthcare fields (Ph.Aut., RN and other)
• Minimum of four (4) years of experience in site monitoring/management is required
• Experience in monitoring and/or coordinating clinical trials is mandatory
• Excellent written and verbal communication skills
• Ability to manage multiple priorities across multiple and complex trials
• Knowledge of current GCP/ICH guidelines applicable to the conduct of clinical research
• Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint and the use of a laptop

Responsibilities

• Participates in the preparation and execution of Phase I to IV clinical trials
• Oversees the progress of clinical investigations by conducting interim site assessment, initiation, and closure visits
• Monitors clinical trials in accordance with clinical best practices and procedures established by IQVIA and its sponsors
• Collaborates with ISS to coordinate activities with the site in preparation for the launch of the study
• Conducts study initiation activities, reviews protocol, regulatory issues, study procedures with site staff, and provides training
• Helps resolve any issues to ensure compliance with site file audits in collaboration with the ISS
• Ensures adherence to good clinical practices, investigator integrity, and adherence to study procedures through on-site monitoring visits
• Prepares monitoring reports and letters according to the timelines defined in IQVIA SOPs
• Documents the responsibility, stability, and storage conditions of clinical trial material as required by the sponsor
• Examines the quality and integrity of clinical data through internal review and on-site source verification
• Serves as the primary contact between IQVIA and the investigator; coordinates all correspondence
• Conducts study closure visits in accordance with the study-specific clinical follow-up plan
• Attends and participates in investigators’ meetings for assigned studies
• Serves as a mentor for CRA assistants and those who are new to the business and/or study

Preferred Qualifications

• Previous experience in a clinical research organization (CRO) preferred
• Previous project team leadership experience preferred
• Working knowledge of budget management preferred
• Experience in organization of clinical research (ORC) preferred
• Must be able to travel domestically and internationally approximately 65% to 85%