- 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
- College/University degree in Life Sciences, Pharmacy or an equivalent combination of education, training & experience
- Participation in clinical projects as a Lead/Senior Monitor
- At least 4 years of experience as Senior CRA
- 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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Lead CRA - Bogotá, Colombia - PSI
Descripción
Job Description
In this role, 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:
Qualifications
Additional Information
Advance your career in clinical research, overseeing a variety of tasks and growing with the company. You will work closely with driven and dedicated cross-functional teams, get all support and ownership of your projects.
