Clinical Research Associate / Senior Clinical Research Associate
Theorem Clinical Research - Pennsylvania

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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

Job Description:
RESPONSIBILITIES

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.