PRAHS

  • Central Monitoring Associate 1

    Job Locations - | Argentina-Buenos Aires
    Posted Date 3 weeks ago(5/3/2018 9:55 AM)
    ID
    2018-46695
  • Overview

    The Central Monitoring Associate (CMA) – Product Registration will remotely monitor the progress of clinical studies at investigative sites and ensure clinical trials are conducted, recorded and reported in accordance with  the trial protocol, applicable Standard Operating Procedures (SOPs),  ICH-GCP, applicable local regulations and requirements.

    Responsibilities

    Responsibilities include but are not limitedto:

    • Following PRA and/or sponsor SOPs and work instructions being knowledgeable of the protocol and applicable sections of the Analytics Review Plan, Clinical Management Plan, edit specifications and related Clinical Informatics trial documents, Case Report Form modules and completion guidelines according to the trial protocol.
    • Performing Central Monitoring, performing  off-site monitoring visits and site contact on a regular basis as defined in the scope of work
    • Working in conjunction with the CRA to implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
    • Ensuring consistency and accuracy of clinical trial data by performing  off-site data review
    • Providing regular site status information to team members and updating trial management tools
    • Completing monitoring activity documents as required by PRA SOPs or other contractual obligations 
    • Working closely with other clinical team members to facilitate sites communications and the timely resolution of trial and/or clinical issues
    • Escalating site and trial related issues until issues are resolved or closed
    • Supporting sites to ensure timely query resolution, remotely assessing IP accountability and compliance by the site
    • Verifying Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines
    • Communicating with investigative sites, updating applicable tracking systems, ensuring all site required training is completed and documented in a timely manner
    • Assisting with facilitation of audits and audit resolution, reviewing and ensuring timely site data entry.

    In addition to the core CMA tasks outlined above the CMA may also undertake tasks outlined in the IHCRA and/or CRA Job description. The CMA may have overall accountability for site management. 

    • Attending, preparing for and participating in internal and external meetings as required, attending Investigator meetings as required.

    Qualifications

    • Minimum 2 years clinical trial support or pharmaceutical industry experience
    • Read, write, and speak fluent English; fluent in host country language
    • Knowledge of ICH-GCP and local regulatory requirements 
    • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution or a licensed healthcare professional (i.e. registered nurse) 
    • Prior experience using Clinical Data Management Systems 
    • Basic knowledge of medical terminology 
    • An advanced degree (e.g.  M.S., M.B.A., PharmD, etc)
    • On site monitoring experience





    PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.

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