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.
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.
Requisition ID : 156466