Performs and coordinates all aspects of the clinical monitoring and site management process in accordance with ICH GCP, FDA guidelines, local regulations and PPD 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. Develops collaborative relationships with investigational sites

Conducts site visits to assess protocol and regulatory compliance and manages required documentation. Responsible for ensuring that data will pass international quality assurance audits. Develops collaborative relationships with investigational sites

and Experience:  (Required education, training, licenses, accreditation or certification and quantity and type of directly related experience. In many cases an “equivalency,” consisting of a combination of education and prior directly related experience, is sufficient for the individual to perform the job satisfactorily.)

 


Bachelor’s degree in a science related field or a Registered Nursing certification or equivalent certification/licensure from an appropriately accredited institution.  In some cases an equivalent combination of education, professional training, and experience that provides the required Knowledge, Skills and Abilities may be considered.

Valid Driver’s License where applicable

Minimal clinical monitoring experience that provides the required knowledge, skills, and abilities.  In some cases previous experience 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.


 

 

 

Knowledge, Skills and Abilities:

 

 


Basic medical/therapeutic area knowledge and understanding of medical terminology

Ability to attain and maintain a working knowledge of GCPs and applicable SOPs

Good oral and written communication skills, with the ability to communicate effectively with medical personnel

Customer focus

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