Clinical Research Associate (CRA) - Milan, Italy
PPD
Segrate (MI), Italy, Italy
6 gg fa

PPD is currently looking to hire an experienced CRA I or CRA II to join our office based clinical operations team in Segrate, Milan.

CRAs at PPD work on behalf of a number of sponsors and in various therapeutic areas. They are supported by a project team that includes a Project Assistant and Remote Site Monitor, meaning our CRAs can focus on quality. Responsibilities :

  • Perform and coordinate all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD SOP's.
  • Monitor investigator sites to ensure the accuracy and validity of CRF entries in relation to patient records / clinic notes (source document verification).
  • Conduct 6-8 visits on average per month
  • Document observations in reports and letters in a timely manner using approved business writing standards.
  • Escalate observed deficiencies and issues to clinical management expeditiously, present potential solutions and follow all issues through to resolution
  • Ensure that data will pass international quality assurance audits.
  • Manage the essential documents, as required by local regulations and ICH GCP, before, during and after a clinical trial.
  • Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites.
  • Qualifications :

    Education and Experience :

  • Bachelor's degree in a life sciences related field
  • At least 1 year of independent monitoring experience as a CRA
  • Experience across a variety of therapeutic areas, any experience in Oncology, Cardiovascular, Gastro or CNS advantageous.
  • Certified according to Italian CRO Decree
  • Valid driver's license where applicable.
  • Knowledge, Skills and Abilities :

  • Proven clinical monitoring skills
  • Demonstrated understanding of medical / therapeutic area knowledge and medical terminology
  • Demonstrated ability to attain and maintain a working knowledge of GCP's and applicable SOP's
  • Good oral and written communication skills in Italian and English.
  • Ability to maintain customer focus through the utilization of good listening skills, attention to detail and the ability to perceive customers’ underlying issues .
  • Apply now or contact Adam Davis, Senior Recruiter on adam.davis ppdi.com for more information.

    Additional Information

  • Requisition ID : 156466
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