Job FunctionNIEUW: (Senior) CRA
Short DescriptionVoor een van mijn klanten, een grote, internationale farmaceut, ben ik op zoek naar een ervaren CRA. De functie kan zowel officebased als homebased ingevuld worden.
Company ProfileOnze klant is een grote, internationale farmaceut met een goed gevulde pijplijn en interessante doorgroeimogelijkheden.
Function Profile• 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 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 the company 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% on average.
Function CriteriaEducation 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 with a demonstrated high level of expertise in all aspects of clinical monitoring
• Fluency in English and Dutch
• 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

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