Clinical Research Associate | Netherlands

Tasks and responsibilities of the Clinical Research Associate

• Monitor clinical research in accordance with the protocol, SOPs, applicable laws and ICH-GCP guidelines, including visit report compilation and follow-up within the set timelines;
• Perform feasibility, site selection, initiation, monitoring and close out visits in accordance with contracted scope of work, using good clinical practices, applicable laws and regulations SOPs and Work Instruction;
• Escalate quality issues to Clinical Team Lead and/or Linemanager;
• Manage the progress of assigned studies to support recruitment and enrolment, CRF completion, and data query generation and resolution, essential document collection and filing study documentation;
• Train investigators and site staff in the correct implementation of the protocol and study-specific procedures and establish an effective work relationship with sites to manage ongoing project expectations and issues;
• Support the investigator during inspections by healthcare authorities or audits;
• Be involved in SOP development, maintenance and training.

• Higher level of education preferably in an (bio)medical field;
• At least two years of relevant on-site experience, as a CRA, in clinical research;
• Up- to- date knowledge ICH-GCP guidelines, clinical trial regulations and legislation;
• Effective oral and written communication skills in English and Dutch;
• Proactive, strong communication and coordination skills;
• Ability to work independently as well as in a team matrix organization;
• Ability to travel on an irregular base;
• Practical knowledge of Microsoft Office;
• Driver’s License.

An open culture in an innovative and dynamic environment with inspiring colleagues and good working conditions. An environment where you have room to be creative, take initiative and have direct influence on the way we work.

We are located in a brand new, modern office in Zeist. Our employees have the flexibility to work from home and from the office.

Are you interested? Reply directly via LinkedIn.

If you have further questions, you can contact Marjolijn Woudstra (Senior Recruitment Business Partner a.i.) via whatsapp/call: +31 6 28 25 65 82