Senior Clinical Research Associate I

Summary

Join PSI, a leading Contract Research Organisation, as a Senior CRA I and work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects. You will build and maintain relationships with clinical sites and investigators, focusing on subjects’ rights, safety and well-being and quality of data compliance. This freelance, home-based position offers the possibility to visit the Leuven office. The role involves conducting and reporting monitoring visits, driving study startup, performing CRF reviews, managing site communication, supervising study activities, acting as a point of contact for support services, supporting quality control, participating in feasibility research, and supporting regulatory submissions. PSI focuses on its people and invests in their professional development and success, offering a straightforward recruitment process with guidance and support.

Requirements

• BSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in Belgium, ideally on multiple projects at a time
• Demonstrable experience in all types of monitoring visits in Phase II and/or III
• Strong written and verbal communication skills
• Fluency in Dutch and English, professional proficiency in French is an asset
• Intermediate to Advanced knowledge of MS Office
• Ability to plan, multitask and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills are essential
• As you will be monitoring multiple sites, you must have a full and clean driver's license, and the ability to travel

Responsibilities

• Conducting and reporting all types of onsite monitoring visits
• Driving the study startup phase (if applicable)
• Performing CRF reviews, source document verification and query resolution
• Be responsible for site communication and management
• Supervising study activities, timelines, and schedules for each site
• Acting as a point of contact for in-house support services and vendors
• Supporting quality control, such as compliance monitoring and reports review
• Participating in feasibility research
• Supporting the regulatory team in preparing documents for study submissions and regulatory approval

Preferred Qualifications

Experience supporting Oncology studies is beneficial, but not essential