The Clinical Research Associate II is responsible for site monitoring, management of study files, conducting visits, liaison with vendors, and ensuring compliance with regulatory requirements.
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).
Learn more about our EEO & Accommodations request here.
Top Skills
Clinical Monitoring
Ich Gcp Guidelines
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