Covance Clinical Research Associates (CRA) in Novosibirsk in Russia

Job Description:

Dear reader, as the Russian government has introduced the Data Protection Law we are obliged to initialy store private documents on Russia located servers. Because of that we kindly ask you to apply for this position here: https://hh.ru/vacancy/19778212

We are always looking for talented clinical research professionals for Clinical Research Associate positions (CRA) in Russia, Novosibirsk!

Summary:

CRA positions available to work within our Phase II-IV Clinical Operations Teams, Early Clinical Development or through our CoSource division directly with pharmaceutical companies. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Russia. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

Requirements:

  • Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

  • Excellent understanding of Serious Adverse Event reporting

  • Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Russia.

  • Fluency in both English and Russian

USPs of CRA role:

  • Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets

  • Join a stable team of CRAs across Russia and benefit from outstanding training and development, both initially and throughout your career

  • Join a company where people tend to stay for 6-10 years rather than 1-3!

  • Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.

Duty Highlights:

As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities include:

  • All aspects of site management as prescribed in the project plans

  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks

  • Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements

  • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.

  • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems

Other Information:

These roles are full time & permanent positions employed through Covance.

Key words:

Clinical Research, CRA, SCRA, Clinical Research Associate, GCP, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, CRA II, CRA III, LCRA, Oncology, Cardiovascular, Neuroscience, Immunology, Infectious Diseases, Metabolism, Field Based, Home Based, CRO, Pharmaceutical, Russia, Novosibirsk

Requisition ID: 68595BR

Job Category: Clinical Research Associate

Locations: Russia, Russia - Moscow

Shift: 1

Job Postings: Dear reader, as the Russian government has introduced the Data Protection Law we are obliged to initialy store private documents on Russia located servers. Because of that we kindly ask you to apply for this position here: https://hh.ru/vacancy/19778212

We are always looking for talented clinical research professionals for Clinical Research Associate positions (CRA) in Russia, Novosibirsk!

Summary:

CRA positions available to work within our Phase II-IV Clinical Operations Teams, Early Clinical Development or through our CoSource division directly with pharmaceutical companies. As an experienced CRA you’ll be involved in initiation, routine & close out visits concentrating on sites in Russia. Successful candidates will enjoy the benefits of working for a company that values a WORK / LIFE BALANCE!

Requirements:

  • Ability to monitor Clinical study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines

  • Excellent understanding of Serious Adverse Event reporting

  • Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits) in Russia.

  • Fluency in both English and Russian

USPs of CRA role:

  • Unlike some CRA roles you will not be pushed to satisfy unrealistic ‘monthly visit’ targets

  • Join a stable team of CRAs across Russia and benefit from outstanding training and development, both initially and throughout your career

  • Join a company where people tend to stay for 6-10 years rather than 1-3!

  • Join a genuinely friendly and supportive company where they allow individuals to take ownership of their own performance.

Duty Highlights:

As a CRA you will manage all aspects of study site monitoring according to SOPs, GCP, and ICH guidelines, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files. Responsibilities include:

  • All aspects of site management as prescribed in the project plans

  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks

  • Negotiation of study budgets with potential investigators and collaboration with Covance legal department with statements of agreements

  • Serious Adverse Event (SAE) reporting, production of reports, narratives and follow up of SAEs.

  • Case Report Forms (CRF) review; query generation and resolution against established data review guidelines on Covance or client data management systems

Other Information:

These roles are full time & permanent positions employed through Covance.

Key words:

Clinical Research, CRA, SCRA, Clinical Research Associate, GCP, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, CRA II, CRA III, LCRA, Oncology, Cardiovascular, Neuroscience, Immunology, Infectious Diseases, Metabolism, Field Based, Home Based, CRO, Pharmaceutical, Russia, Novosibirsk

Education/Qualifications: *

Experience: *

EEO Statement:

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.