CRA I - CRA II

Summary of Responsibilities:

Responsible for all aspects of study site monitoring including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned.

Responsible for all aspects of site management as prescribed in the project plans.

Qualifications (Minimum Required):

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate.

• Thorough understanding of ICH GCP Guidelines and understanding of local regulatory requirements.

• Thorough knowledge of monitoring procedures.

• Basic understanding of the clinical trial process.

• Fluent in local office language and in English, both written and verbal.

• Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required):

• External Candidates:

• University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). AND

• A minimum of 1 years of Clinical Monitoring experience.

• Internal Candidates:

• Internal candidates with a minimum of 1 years of Clinical Monitoring experience.

• Ability to monitor study sites independently according to monitoring plan, project requirements, SOPs, and ICH GCP guidelines.

• Ability to work with minimal supervision.

• Have an understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.

• Good planning, organization, and problem-solving abilities.

• Works efficiently and effectively in a matrix environment.

Physical Demands/Work Environment:

• Travel Requirement is 60% of the time (traveling to study sites).

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