Clinical Research Assosiate 2

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 2 years of Clinical Monitoring experience.
• Internal Candidates:
• Internal candidates with a minimum of 2 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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