CONTRACT RESEARCH AND CONSULTING ORGANIZATION
 
 

Looking for CRAs

1 September , 2016

Clinmark, a dynamically growing polish CRO, specializing in clinical research in CEE and global clinical consulting. We are looking for talented and motivated Clinical Research Associates to join our team.

 

KEY RESPONSABILITIES INCLUDE:

  • Identify, select, train and initiate appropriate investigational sites for clinical trials
  • To submit clinical trials to RA and EC
  • To negotiate site contractual agreements
  • To monitor and manage the sites to ensure study protocol, SOPs, regulatory and ICH –GCP compliance as well as to ensure the rights and well-being of human subjects are protected and the reported trial data are accurate, complete, and verifiable from source documents
  • To collect and review of essential documents required to study execution
  • To ensure effective resolution of issues identified during the course of the study
  • To maintain study files
  • To prepare, collect and review documentation supporting payments for the sites

 

 

 

QUALIFICATIONS AND EXPERIENCE   

  • University degree (medical or biological science degree preferred) 
  • Organized and well structured 
  • A minimum of 1,5 years of clinical trial monitoring experience is preferred.
  • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines
  • Demonstrate the ability to work independently and within the team
  • Willing to travel
  • Good English knowledge in speaking and writing

 

 

 

 ANY OTHER INFORMATION  

  • Expected to travel up to 60% of working time