Senior Clinical Research Associate I (SCRA1), FSP modelFortrea • Kuala Lumpur, Kuala Lumpur, Malaysia
Senior Clinical Research Associate I (SCRA1), FSP model
Fortrea • Kuala Lumpur, Kuala Lumpur, Malaysia
30+ hari lalu
Penerangan pekerjaanUniversity or college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology. In lieu of the above education requirement, candidates with a minimum of 3 years relevant clinical research experience in pharmaceutical or CRO industries will be considered. Thorough knowledge of regulatory requirements including a basic understanding of regulatory requirements in other countries. Thorough understanding of the drug development 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. Typically three (3) years of clinical onsite monitoring experience. Have a full understanding of Serious Adverse Event (SAE) reporting, process production on reports, narratives and follow up of SAEs. Advanced site monitoring skills. Advanced study site management skills. Advanced registry administration skills. Ability to work with minimal supervision. Valid Driver's License. Travel requirements : 60-80% Mid-Senior level Full-time Research, Analyst, and Information Technology
Overview
The Senior Clinical Research Associate I (SCRA I), FSP model, is responsible for site monitoring and site management in accordance with Fortrea, Sponsor Standard Operating Procedures, and regulatory guidelines. The Senior CRA I ensures the implementation of project plans, may lead projects of limited scope, and may have line management responsibilities or act in the project role of Local Project Coordinator or Lead CRA as assigned.
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)
Experience (Minimum Required)
Physical Demands / Work Environment
Learn more about our EEO & Accommodations request here.
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