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Job Details

Clinical Research Associate II - Bucharest, Romania

Company: Covance
Location: Bucharest
Reference: 15558
Closing Date: 27 Apr 18
Type: Permanent
Salary (£): Competitive
Benefits:

Job 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 Romania. Successful candidates will enjoy the benefits of working for a company that values a WORK/LIFE BALANCE!

Requirements:

Requirements:

  • At least two years’ experience in CRA role
  • Experience on at least two different therapeutic arias
  • 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 Romania.
  • Fluency in both English and Romania

 

Strong recommended experience:

  • Oncology trials.
  • Start-up phase.
  • Setting and working with external facilities or vendors.
  • Guarantees all the activities related to start up, initiation, conduct and completion of clinical trials for the assigned sites are performed in accordance with ICH-GCP, QDs and local regulations.

 

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 Romania 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. 

Apply for this job: Clinical Research Associate II - Bucharest, Romania

Contact Information:

Address:  Covance- Warsaw


Poland
Tel: 
Fax: 
Website:  Visit Our Web Site

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