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).
Learn more about our EEO & Accommodations request here.
