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 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 legal department with statements of agreements as assigned;
• Interact with internal work groups to evaluate needs, resources and timelines;
• Assist with training, mentoring, and development of junior employees, e.g. co-monitoring (for CRAs II);
• Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned (for CRAs II).
Required skills, experience and education:
• Minimum 2 years of relevant clinical research experience in pharmaceutical or CRO industries;
• 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.
• Understanding of the clinical trial process;
• Thorough knowledge of ICH Guidelines and GCP including a basic 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.
THERE IS NO BETTER TIME TO JOIN US!
Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran). Your confidentiality and privacy are important to us.