PPD is now looking to appoint a Clinical Research Associate (CRA) within its newly-created Site Intelligence and Activation (SIA) group in Italy
The CRA will performs and coordinates site evaluation visits in accordance with ICH GCP and FDA guidelines and global SOPs to ensure the selection of appropriately qualified sites. They'll work in conjunction with the Country Approval Specialists and Contract Specialists to prepare investigational sites for initiation.
In addition, the role serves as a primary contact with individual investigational sites that conduct clinical trials during the evaluation phase. Successful start-up management contributes directly to operational objectives which in turn have an impact on project profitability. The goal is to take investigational sites to the point of initiation following an ICH GCP and SOP/WPD compliant process as efficiently as possible and within the allocated project budget.Qualifications Education and Experience: University degree in a science related field or a certified health care professional or equivalent certification/licensure from an appropriately accredited institution Considerable clinical research monitoring experience (comparable to 5 years) with a demonstrated high level of expertise in all aspects of clinical monitoring Fluency in English and in the country's native language Valid Driver's License where applicable In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered Knowledge, Skills and Abilities: Expert clinical monitoring skills Expert knowledge of FDA guidelines, GCPs and applicable Standard Operating Procedures Skills to mentor and train other monitors in a positive and effective manner Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology Excellent oral and written communication skills Strong customer focus Excellent interpersonal skills Excellent organizational and time management skills Strong attention to detail Proven flexibility and adaptability Excellent team player with team building skills Effective presentation skills Ability to work independently as required Ability to utilize problem-solving techniques applicable to constantly changing environment Good computer skills: good knowledge of Microsoft Office and the ability to learn appropriate software Fluency in Italian, both written and spoken Good English language and grammar skills PPD is an Equal Opportunities Employer