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Job Details

Clinical Research Associate II - Vienna, Austria

Company: Covance
Location:
Reference: 68017BR
Closing Date: 18 Aug 17
Type: Permanent
Salary (£): Competitive
Benefits:

Job Summary:

Do you know Covance is one of the most stable, fastest growing global Contract Research Organization? For example, our Clinical Development teams have supported the development of one-third of all prescription medicines in the market today and of 47 out of the 50 best-selling oncology drugs.

Requirements:

We are currently recruiting for a Clinical Research Associate II in Vienna, Austria for our Flexible Solutions team.
As an Experienced CRA you'll be involved in initiation, routine & close out visits concentrating on sites in Austria. 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 Austria.
  • Fluency in speaking and writing both English and German
  • Oncology Experience 
  • At least 2 years of Experience as CRA including monitoring oncology studies Phase III
  • Life Science Degree


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 Austria 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:

  • Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
  • Responsible for all aspects of site management as prescribed in the project plans
  • General On-Site Monitoring Responsibilities
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
  • Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data
  • Ensure the resources of the Sponsor and Covance are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Covance travel policy
  • Travel, including air travel, may be required and is an essential function of the job
  • Prepare accurate and timely trip reports
  • Responsible for all aspects of registry management as prescribed in the project pla
  • Undertake feasibility work when requested
  • Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study related documentation, organization of meetings and other tasks as instructed by supervisor
  • Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
  • Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
  • Assist with training, of new employee, e.g. co-monitoring
  • Coordinate designated clinical projects as a Local Project Coordinator (with supervisor, if applicable), and may act as a local client contact as assigned
  • Perform other duties as assigned by management


EEO Employer Covance is committed to diversity in the workplace and is an equal opportunity employer (Minority/Female/Individual with Disability/Veteran/Sexual Orientation/Gender Identity). Your confidentiality and privacy are important to us.

Apply for this job: Clinical Research Associate II - Vienna, Austria

Contact Information:

Address:  Covance- Warsaw


Poland
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