About this role
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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