The Senior Clinical Research Associate (CRA) will strengthen our team within Clinical Operations Department, supporting our many projects. As an experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field of clinical research, you will be a productive member of the team. You enjoy start up, enrollment, follow up and closure of clinical trial activities, and mainly monitoring the progress of clinical studies at the site level.
ₒ Clinical Site Start-up:
- Support with identification of clinical sites
- Preparation of packages for ethical committee (EC) submissions
- Submissions to ECs
- Preparation of site budget, negotiations of site budget
- Organization, preparation, performance, follow-up of Site Qualification visits, Site Initiation visits
ₒ Clinical Site Management:
- Organization, performance, follow-up of trainings
- Organization, preparation, performance, follow-up of Monitoring visits, Close-out visits
- Identification, communication, resolution of site-related matters, issue escalation
- Site leadership
ₒ Development, writing, review of task-related SOPs
ₒ Support clinical supply chain
- Bachelor or Master degree in (para-) medical or scientific field
- Involvement in study start-up and EC submissions in at least 2 countries
- At least 7 years of clinical research experience including monitoring, or in pharmaceutical data management including activities during data base locks, or as a study coordinator
- Experience with oncology in early phases
- Experience with Advanced Therapy Medicinal Products (ATMPs) is an advantage
Skills & Competencies:
- Very strong attention to details
- Work precisely as per procedures, rules and regulations
- Objective and analytical
- Planning & Organizing skills
- Team spirit
- Excellent English, French and Dutch knowledge (“trilingual”, oral and written), additional languages are an asset
- Strong communication skills
- Hands-on attitude
- An attractive salary in line with your experience and skills.
- Fringe benefits including a company car, medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.