As CRA you will be responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits.
• Site administrating and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP;
• Recruiting potential investigators, preparing EC submissions, translating study-related documentation, organizing of meetings and other tasks as instructed by supervisor;
• Completing Serious Adverse Event (SAE) reporting, processing production of reports;
• Negotiating study budgets with potential investigators and assisting the Covance legal department with statements of agreements as assigned;
• Assisting with training, mentoring, and development of new employees, e.g. co-monitoring.
• University Degree (life science) or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology);
• Fluency in local and English language
Required skills, experience:
• Minimum 1,5 years of relevant clinical research experience in pharmaceutical or CRO industries
• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Thorough knowledge of monitoring procedures.
In return, we offer you the opportunity to develop your career with an international organization; to pursue further training and to take advantage of our flexible conditions and attractive remuneration package.
For more information and to apply online visit www.covancecareers.com, quoting the appropriate reference number: 30350BR.