For one of our valued clients we are currently looking for a "CRA"
As a Clinical Site Monitor you are the first point of contact for the investigational site staff. You guide the site throughout the clinical study and make sure that it is conducted in accordance with all applicable guidelines. You are part of a team of professionals working in a Functional Service Provider setting.
- You initiate sites, perform onsite/remote monitoring visits and conduct close outs
- You are responsible for operational site management
- You will work in a risk based study execution model
- You ensure detailed corresponding reports and administration
- You train your investigational site staff on study specific procedures
- You build and maintain solid and long-term professional relationships with investigators and site staff
- You facilitate subject enrolment at the site level with focused patient recruitment strategies and action plans
- You continuously assess site compliance and data quality/integrity
- You respond to site-related queries and escalate site-related issues
- You actively contribute to results oriented department goals
Do the above responsibilities fit you like a glove?
Download your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone off course.
- Bachelor or Master degree in a life science orientation
- Work experience in clinical research (obtained working on clinical trials in a biotech, pharmaceutical or CRO company, or other relevant clinical setting)
- Knowledge and experience in international standards (GCP/ICH), international (FDA, EMA) and local regulations
- Very good knowledge of Dutch, French and English
- Able to work in a changing and innovative environment
- Strong organizational and interpersonal skills
- Proven expertise in effective communication, in managing multiple priorities and in computer literacy
- Able to work very independently within your area of responsibilities
- An eye for detail and affinity with administration, meticulous and quality-minded
- Willing to work fully homebased
- Driver's license B
- A balanced salary package based on your capabilities and experience.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy Number: 16449