Senior CRA II / Lead Monitor
PSI CRO
Bucharest, Romania
4 zile în urmă

Company Description

We are the company that cares for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,300 driven, dedicated and passionate individuals.

We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

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.

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)
  • 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
  • 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
  • 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.

  • Excellent and flexible working conditions
  • Extensive training and friendly, collegial team
  • Competitive salary and benefits package
  • Opportunities for personal and professional growth
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