Clinical Research Associate

ბიომაპას

Biomapas is a functional and full outsourcing solution provider to the global life science industry, with key expertise in Clinical Trials,

Regulatory Affairs and Pharmacovigilance. With headquarters in Lithuania and offices in Switzerland, Russia, Georgia, Ukraine, Poland, Kazakhstan and Sweden,

Biomapas operations are spread over 5 continents, concentrated in Europe, Russia and former CIS region. 

 

Biomapas is looking for a positive and observant person to join our team as a Clinical Research Associate in Georgia.   

 

Role responsibilities: 

  • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice;   
  • Perform feasibilities and support start up phase;  
  • To ensure that clinical trial is conducted, documented and data are received properly in accordance with protocol, ICH-GCP, other applicable regulatory requirements and Sponsor‘s requirements to carry out the following activities when relevant and necessary to the trial quality;  
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage recruitment, ongoing project expectations and issues;  
  • Perform regulatory document review/local adaptation and submission to regulatory authorities;  
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation;  
  • Prepare clinical trial documents and maintain correspondence appropriately; to prepare and appropriately maintain clinical trial files, to store and archive them in accordance with Sponsor or UAB Biomapas requirements;  
  • Negotiating study budgets with potential investigators/sites and assisting in agreements negotiation;  
  • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.  

 

Role requirements: 

  • University degree in Medicine, Pharmacy, Health Science, Life Science, Biomedicine field/studies;   
  • Fluent English and Georgian language;  
  • Good knowledge of, and skill in applying, applicable clinical research regulatory requirements; i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines as well as appropriate Georgian legislation;  
  • Computer skills including proficiency in use of Microsoft Office, EDC and other clinical trial related systems and platforms;  
  • CRA experience 2-5 years.  

 

In Biomapas you will find supportive work environment with guarantee for professional and personal development, as well as competitive salary and benefits and many more initiatives that will make your daily office life comfortable. We provide flexible working conditions (possibility to work homebased). 

 

Please apply to cv@biomapas.com  

Be kindly informed that only selected candidates will be contacted. 


სრული განაკვეთი
თბილისი
გამოცდილების დონე: საშუალო
სქესი: ნებისმიერი
გამოქვეყნებუილია: 24/10/2020
ბოლო ვადა: 07/11/2020

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