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Senior CRA

Kiev, Kiev
Senior Clinical Research Associate
Freelancer or permanent employee in Ukraine 


For our team in Ukraine we are hiring a a new team member in the area of CRA.
 
Overview
  • Biorasi is an award-winning fast growing, full-service, global CRO 
  • Headquartered in Aventura, Florida, with regional offices and operations around the world
  • Place for work: Ukraine
  • Tasks: Clinical Research, Monitoring and a wide range of variety 
 
As a Clinical Research Associate your role is for example:
  • Organization of all types of site visits including Site Selection, Initiation, Monitoring, and Close-out
  • Responsibility of the drug accountability and other monitor activities to assure adherence to Good Clinical Practices (ICH GCP), SOPs, and study protocols
  • Ensuring the availability of selected study centres, adequate qualification resources, suitable volunteers and qualified examiner
  • Monitoring of clinical trials including the trial-specific monitoring plan and compliance with regulations, ICH/GCP guidelines and IRB approvals
  • Responsibility for various documents and approvals such as submissions/notifications to national health authorities, submissions to IRB/Ethics Committees, AE/SAE expertise, updates, protocol changes, safety reports
  • Working with the Regulatory Division for timely results
  • Contact person for the clinical sites and reporting to the study director
 
That is your Candidate Profile
  • Bachelor’s degree, preferably in biomedical sciences or related scientific discipline
  • Prefer a minimum of 4 years monitoring experience
  • Thorough Knowledge of FDA regulations and ICH/GCP guidelines
  • Ability to travel up to 70% depending on project
  • Very good skills in MS-Office
  • Fluent knowledge of the local language and very good knowledge of English
 
You are interested to get a new job and a new challenge. We are glad to know you.
Please send your CV to our recruiter Elena – eescolano@biorasi.com or use our apply button.
 
 
Biorasi is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Biorasi is also committed to compliance with all fair employment practices regarding citizenship and immigration status.
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