As Clinical Research Associate (CRA) you will perform and coordinate clinical monitoring and site management process in accordance with ICH Good Clinical Practices, FDA guidelines, local regulations and PPD Standard Operating Procedures.
You will conducts site visits to assess protocol and regulatory compliance and manage required documentation. Responsible for ensuring that data will pass international quality assurance audits.
Represent PPD in the global medical research community and develops and maintain 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 contribute to the development of junior clinical team members.
Will be required to travel 60-80% on average.
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
Clinical research monitoring experience with a demonstrated high level of expertise in all aspects of clinical monitoring is preferred
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 :
You should :
Possess expert clinical monitoring skills
Have solid knowledge of FDA guidelines, GCPs and applicable SOPs
Be able to mentor and train other monitors
Evaluate medical research data and demonstrate solid knowledge of medical terminology
Possess strong customer focus
Have excellent interpersonal skills, show flexibility
Have excellent time management skills and strong attention to detail
Collaborate effectively within a team, but also work independently if required
Possess good presentation skills
Utilize problem-solving techniques applicable to constantly changing environment
Have Good computer skills : good knowledge of Microsoft Office and the ability to learn appropriate software
WE OFFER YOU : The chance to work in a dedicated team of bright professionals where we will work together for a meaningful goal and will provide you with the opportunity to enrich your personal and professional skills.
PPD is an equal opportunities employer. Additional Information
Requisition ID : 160149