Overview
The Senior CRA I is responsible for site monitoring and site management. Responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines. The Senior CRA I assures the implementation of project plans, as assigned. Function as leader for projects of limited scope, as assigned. Assume line management responsibilities, as assigned. Act in the project role of a 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)
* University 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.
Experience (Minimum Required)
* 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.
Physical Demands / Work Environment
* Travel requirements: 60-80%
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