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 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
Qualifications
- 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
- Experience supporting Oncology studies is beneficial, but not essential
- 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.
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.
