Are you a trilingual Senior CRA and want to be part of a growing, dynamic, global company with a very nice familial team spirit? Don't hesitate and apply now!
Job Description:
As a Senior CRA, 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.
Responsibilities:
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
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, French and English
- 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.
- Existing right to work in Europe required
Contract information:
- Freelancer
- September start date
- 0.6 FTE (As of Nov/Dec possibility to increase to FT FTE)
- Fully remote
