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.
Education and Experience :
Bachelor's degree in a science related field or a Registered Nursing certification or equivalent certification / licensure from an appropriately accredited institution
Minimal clinical monitoring experience that provides the required knowledge, skills, and abilities. In some cases previous experience (comparable to 2 years) in a clinical environment where experience is gained in clinical trials, medical terminology, medical research, clinical research or health care OR experience in a health sciences field with formal training in medical terminology and anatomy may be considered
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 :
Basic medical / therapeutic area knowledge and understanding of medical terminology
Ability to attain and maintain a working knowledge of Good Clinical Practices and applicable Standard Operating Procedures
Good oral and written communication skills, with the ability to communicate effectively with medical personnel
Good interpersonal skills
Good organizational and time management skills
Attention to detail
Flexibility and adaptability
Ability to work in a team or independently as required
Good computer skills : good knowledge of Microsoft Office and the ability to learn appropriate software
Good English language and grammar skills
PPD is an Equal Opportunity Employer
Latin America-Argentina-Buenos Aires-Buenos Aires