Job Description
As a Clinical Site Monitor for our client 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.
Responsibilities
- 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
- Bachelor or Master preferably in sciences or qualified nurse
- Work experience as CRA (minimum 2 years) or study coördinator
- 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