Senior Clinical Research Associate I (SCRA1), FSP model

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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