Cra I - Cra 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 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). Learn more about our [EEO & Accommodations request here](https://careers.fortrea.com/us/en/eeo-and-accommodations).