2023-08-23 14:48:55

Clinical Research Associates - all levels - up to 5K sign-on bonus!

CVKeskus.ee klient

Job Description

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. Responsibilities:
  • 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).
  • Requirements

    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.
  • Company offers

    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! Education/Qualifications * Experience * EEO Employer 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. Apply