Job Description
In the role of Sr CRA II (Lead Monitor), you will manage local Monitors, supervising clinical monitoring and site management activities to verify the protection of trial subjects’ rights, safety and well-being, data quality and study compliance on a country/regional level.
Only CVs in English will be considered.
You will:
- Facilitate regional projects as Lead Monitor and supervise study activities, timelines and schedules
- Train Monitors in annotated monitoring visit reports
- Review monitoring reports and support monitors in their activities
- Act as the main communication line between Monitor and Regional Lead
- Facilitate site budgets and contract negotiations
- Be a point of contact for in-house support services and vendors
- Communicate with internal project teams regarding study progress and lead project team calls on the country level
- Participate in quality control and compliance monitoring
- May need to monitor and manage sites (if applicable)
- May need to supervise monitors on site
- Oversee and maintain study-specific and corporate tracking systems at site and country level
Qualifications
- College/University degree in Life Sciences, Pharmacy, RN or an equivalent combination of education, training & experience
- Participation in clinical projects as a Lead/Senior Monitor
- Independent on-site monitoring experience
- Full working proficiency in English and Spanish
- PC skills to be able to work with MS Word, Excel and PowerPoint
- Ability to plan, multitask and work in a dynamic team environment
- Communication, leadership, and problem-solving skills
- Ability to travel
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