Sr CRA II - FSP Team
$47,800–$63,000 year
On-siteMilan, Lombardy, Italy
Job Summary
Conduct routine monitoring, close-out visits, and pre-study initiation for clinical sites while managing study files and liaising with vendors. Verify informed consent adherence, review source documents for data integrity, and monitor for missing or implausible entries. Manage small projects as a Local Project Coordinator or Lead CRA, including feasibility work, protocol development, and registry administration. Track and follow up on Serious Adverse Event reporting, coordinate investigator meetings, and negotiate study budgets. Independently perform CRF reviews, query resolution, and QC visits while ensuring audit readiness. Prepare accurate trip reports and manage travel expenses according to company policy.
Required Qualifications
- University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
- An equivalent amount of experience can be substituted as appropriate
- In lieu of the above education requirement, candidates with a minimum of 6 years recent clinical monitoring experience will be considered
- Thorough knowledge of regulatory requirements
- Thorough understanding of the drug development process
- Fluent in local office language and in English, both written and verbal
- Or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
- Fortrea may consider relevant and equivalent experience in lieu of educational requirement
- Three-Four (3-4) years of Clinical Monitoring experience
- Have a full understanding of Serious Adverse Event (SAE) reporting, process production of 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
- Good planning and organization skills
- Good computer skills with good working knowledge of a range of computer packages
- Advanced verbal and written communication skills
- Ability to train and supervise junior staff
- Ability to resolve project-related problems and prioritizes workload for self and team
- Ability to work within a project team
- Works efficiently and effectively in a matrix environment
- Travel, including air travel, may be required and is an essential function of the job
Desired Qualifications
- Thorough knowledge of company SOPs regarding site monitoring
- Minimum 1 Year experience in a related field (i.e., medical, clinical, pharmaceutical, laboratory, research, data analysis, data management or technical writing)
- Local project coordination and/or project management experience
- Ability to maintain confidentiality of data and information during interactions with staff at all levels and across studies and sponsors
- Demonstrated ability to conduct clinical operations activities most effectively and efficiently
- Methodical approach to work
- Strong understanding of medical and clinical research terminology, and clinical research processes
- An understanding of the basics of physiology, pharmacology, and medical devices (when applicable)
- Strong understanding of the principles of regulatory requirements
- Good computer literacy with working knowledge of PCs, Windows, and Microsoft Office applications
- Good oral and written internal and external communication
- Strong interpersonal team and organizational skills, personal presentation
- The ability to communicate effectively in English
- Experience using a clinical trial management system (CTMS)
- For medical device positions, experience in providing customer service to device end users
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