Clinical Research Associate Lead
hace 11 horas
Job Overview
As a Lead Clinical Research Associate, you will play a key role in managing local Monitors and overseeing clinical monitoring and site management activities to ensure the protection of trial subjects' rights, safety, and well-being, as well as data quality and study compliance on a country/regional level.
Key Responsibilities
- 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.
Requirements
- College/University degree in Life Sciences, Pharmacy, RN, or an equivalent combination of education, training, and 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.
About PSI
PSI is a dynamic and growing company that offers a unique opportunity to advance your career in clinical research. As a Lead Clinical Research Associate, you will work closely with driven and dedicated cross-functional teams, receive all the support and ownership of your projects, and have the chance to grow with the company.
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