Clinical Research Associate

• • Monitors 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;
  • Performs 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;
  • Performs Feasibility, Medical ethics Committee Health authority activity and can be involved in contract negotiation activities with investigator or hospital;
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalates quality issues to Clinical Team Lead and/or Linemanager;
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution;
  • Train investigators and site staff (including laboratory, pharmacy and other staff involved) in the correct implementation of the protocol, the CRF and study-specific procedures and establish regular lines of communication with sites to manage ongoing project expectations and issues. And assists to organize CRA/ Investigator meetings, if applicable;
  • Develops and maintains an effective working relationship with site staff;
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action items by submitting regular visit reports, generating follow-up letters, essential document collection and filing and other required study documentation;
  • Ensures the correct reporting and follow-up of Adverse Events, Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions;
  • Supports the investigator during inspections by healthcare authorities or audits;
  • Is involved in SOP development, maintenance and training.

• Higher level of education preferably in an (bio)medical field;
• At least two years of relevant 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 negotiations 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

• A collaborative and professional work environment.
• Opportunities for professional development and growth.
• A beautiful office location near Slot Zeist, easily accessible by public transport.
• Flexible working arrangements, with options to work from home, in the office, or a combination of both.

If you are interested in this role, please send your CV and motivation letter to vacancies@juliusclinical.com.

Questions?
For further inquiries, feel free to contact Ellen Hunink, HR Business Partner, at +31 621162980.