Regional CRA

Clinical Research Associate 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 SOPs.

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 company in the global medical research community and develops and maintains collaborative relationships with investigational sites and client company personnel. May assist project manager or clinical team manager on assigned projects. Required to travel 60-80% on average.
oBachelor's degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution
oPrevious experience as a clinical research monitor (comparable to 2+ years) that provides the required knowledge, skills and abilities
oValid Driver's License where applicable
oIn some cases an equivalent combination of education, professional training, and experience that provides the required knowledge, skills and abilities may be considered
oEffective clinical monitoring skills
oDemonstrated understanding of medical/therapeutic area knowledge and medical terminology
oExcellent understanding and demonstrated application of Good Clinical Practices and applicable Standard Operating Procedures
oEffective oral and written communication skills, with the ability to communicate effectively with medical personnel
oStrong customer focus
oEffective interpersonal skills
oStrong attention to detail
oEffective organizational and time management skills
oProven flexibility and adaptability
oAbility to work in a team or independently as required
oGood computer skills:
good knowledge of Microsoft Office and the ability to learn appropriate software
oGood English language and grammar skills
oGood presentation skills

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