Loading...
 

Clinical Research Associate

Category:  Clinical Development and Medical
Location: 

Kyiv, Kyivs`ka oblast`, UA

   

Are you an experienced clinical research professional and enjoy driving change in international environment? Are are looking for opportunities to develop your career? If yes, we might be looking just for you! Join Novo Nordisk Ukraine and get a life-changing career!

 

About the department

Clinical department of Novo Nordisk in Ukraine conducting clinical trials II-IV phases according to Good Clinical Practice and local regulatory requirements.

 

The job

Clinical Research Associate performs all required activities to ensure appropriate monitoring of investigator sites and trial execution in accordance with ICH GCP guidelines, applicable SOPs and local regulations.

 

 

Main responsibilities

  • Perform sites feasibility and selection.
  • Communicate with sites for ensuring adequate enrolment rate.
  • Prepare trial documents for submission to IRBs/IECs and Regulatory Authorities.
  • Perform clinical on-site/off-site monitoring activities (source data verification and review, drug accountability, data collection, issue management etc.)
  • Prepare and submit trial documents and MVRs within defined timelines.
  • Maintain and update study related documentation from CRA's area responsibility.
  • Manage and complete reporting of Serious Adverse Events happened within Clinical Trials on site.
  • Provide study related training for Investigators on the routing practice.
  • Update central data base in Clinical Trial Management System regularly.

 

Qualifications

  • You hold University degree (medical/pharmaceutical is preferred).
  • You have 1-2 years of experience in clinical trial monitoring. 
  • Strong knowledge of GCP and local laws and regulations for clinical trials.
  • Your experience and knowledge in local study management/local regulation will be a strong advantage.
  • Experience in preparing documents for submission to IRBs/IECs and Regulatory Authorities.
  • Computer literacy (e.g. MS Office, EDC, IWRS, CTMS, etc.).
  • Excellent verbal and written communication skills in English.
  • Willing and able to travel (up to 50% of the time).
  • Excellent organizational and time management skills as well as working flexibility.
  • Valid driving licence.

 

Working at Novo Nordisk

At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds, and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in. We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.

 

 

Deadline

01 Nov 2021

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 

 

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.