Description
The Senior Clinical Research Associate II (Sr CRA II) is responsible for site monitoring and site management for clinical studies according to Fortrea and/or Sponsor Standard Operating Procedures and Regulatory Guidelines.
The Sr CRA II assures the implementation of project plans as assigned, functions as leader for projects of limited scope, and assumes line management responsibilities as assigned.
Responsibilities:
- Conduct site monitoring and site management for clinical studies
- Ensure implementation of project plans and regulatory guidelines
- Liaise with vendors and study staff
- Verify informed consent procedures and protocol requirements
- Monitor data for missing or implausible data
- Ensure audit readiness at the site level
- Travel to clinical sites and prepare trip reports
- Manage small projects and serve as lead monitor for a protocol or project
- Participate in protocol development and clinical trial report writing
Qualifications:
- University or college degree in a related allied health profession (e.g., nursing licensure)
- 3-4 years of clinical monitoring experience
- Thorough knowledge of regulatory requirements and drug development process
- Fluent in local office language and English
Preferred Qualifications:
- Knowledge of company SOPs regarding site monitoring
- Experience in a related field (e.g., medical, clinical, pharmaceutical)
- Local project coordination and/or project management experience
- Ability to maintain confidentiality and demonstrate effective clinical operations activities
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