Clinical Operations Manager
2 days ago
The Senior Clinical Research Associate is responsible for site monitoring and site management. This role involves responsibility for clinical studies according to Fortrea, and/or Sponsor, Standard Operating Procedures, and Regulatory Guidelines.
- 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.
Responsibilities may include:
- Leading projects of limited scope
- Assuming line management responsibilities
- Acting in the project role of a Local Project Coordinator or Lead CRA
Qualifications:
- 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
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