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Job 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 assure 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.
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 (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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