Company Description

PSI is a leading Contract Research Organisation with 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Senior CRA I, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications. You will build and maintain relationships with clinical sites and investigators. Your focus will be on subjects’ rights, safety and well-being and quality of data compliance.

This is a freelance (contractor) home-based position with a possibility to visit our Leuven office.

Your responsibilities will include:

Conducting and reporting all types of onsite monitoring visitsDriving the study startup phase (if applicable)Performing CRF reviews, source document verification and query resolutionBe responsible for site communication and managementSupervising study activities, timelines, and schedules for each siteActing as a point of contact for in-house support services and vendorsSupporting quality control, such as compliance monitoring and reports reviewParticipating in feasibility researchSupporting the regulatory team in preparing documents for study submissions and regulatory approval

QualificationsBSc or MSc in Life Sciences (or similar), or an equivalent combination of education, training & experienceIndependent on-site monitoring experience in Belgium, ideally on multiple projects at a timeDemonstrable experience in all types of monitoring visits in Phase II and/or IIIStrong written and verbal communication skillsFluency in Dutch and English, professional proficiency in French is an assetExperience supporting Oncology studies is beneficial, but not essentialIntermediate to Advanced knowledge of MS OfficeAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skills are essentialAs you will be monitoring multiple sites, you must have a full and clean driver's license, and the ability to travel. 

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.