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Job Details

Clinical Research Associate II, Moscow

Company: Covance
Location:
Reference: 16980
Closing Date: 26 Apr 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

We are currently looking for talented Clinical Research Associates II to our team in Moscow. You would be working within our Flexible Solutions department dedicated to one sponsor/client. We offer a home based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues.

Requirements:

  • From 6 months to 3 years monitoring experience
  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH Guidelines
  • Excellent understanding of Serious Adverse Event (SAE) reporting
  • Ability to resolve project-related problems and prioritize workload for self and team
  • Previous clinical research monitoring Experience (including pre-study, initiation, routine monitoring and closeout visits).

JOB SUMMARY:

  • Assure the implementation of project plans as assigned 
  • 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 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, is required and is an essential function
  • Prepare accurate and timely trip reports
  • Responsible for all aspects of registry management as prescribed in the project plans
  • 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 employees, g. co-monitoring
  • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
  • Perform other duties as assigned by management

Key words:

Clinical Research, CRA II, Clinical Research Associate, Moscow, Monitor, Monitoring, Senior Clinical Research Associate, CRA I, CRO, Pharmaceutical, CRA

Apply for this job: Clinical Research Associate II, Moscow

Contact Information:

Address:  Head Office
Maidenhead Office Park, Westacott Way, Littlewick Green, Maidenhead
SL6 3QH
England
Website:  Visit Our Web Site

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