|Korte omschrijving||Voor 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.|
|Bedrijfsprofiel||Een grote, internationale farmaceut met een goed gevulde pijplijn en interessante doorgroeimogelijkheden.|
|Functie omschrijving|| 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.
|Functie eisen||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 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
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 skills