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Clinical Research Associate, Bucharest-134597 - Oferta z Jobs.pl

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Clinical Research Associate, Bucharest-134597

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  • The Clinical Research Associate (CRA) performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures.

    Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Responsible for ensuring that data will pass international quality assurance audits. Represents PPD in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel.

    Will assist project manager or clinical team manager on assigned projects and will take a lead role where required. Will support the line manager to mentor, train and contribute to the development of junior clinical team members. Required to travel 60-80% on average.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
    Good English language and grammar skillsIf you are interested in this career opportunity, please submit your CV in English.
    PPD is an Equal Opportunity Employer


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