TRAINING & EXPERIENCE
4 year degree, R.N. or equivalent
3 years monitoring experience
experience monitoring both out-patient and in-patient studies
Knowledge of Word, Excel and Windows
Working knowledge of FDA/ICH GCPs, and government regulations
ability to travel between 60% and 65%
KEY SKILLS & BEHAVIORS
Extensive knowledge of clinical monitoring and applicable regulatory requirements
Attention to detail and highly organized
Ability to work independently
Presentation and training skills
Identification of potential investigational sites
Coordinates and performs comprehensive site management
Conduct of pre-study, initiation, interim and close out monitoring visits
Produces comprehensive visit reports and status reports
Resolves data issues and audit issues
Adherence to the study timelines and budget
Mentors less experienced CRAs
Within International (when applicable)
Collects high quality essential documents and supports completion of ethics committee and regulatory submissions in association with the respective departments in Theorem Clinical Research.
Completes all other assignments given by management or as business needs require.
Theorem Clinical Research is one of the foremost providers of comprehensive CRO services with offices in more than 30 countries and a...