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PSI CRO Linkedin · Posted 25d ago

Senior CRA

Skopje

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Indexed 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, mid-size company founded in 1995, we bring together more than 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.

Job Description

We are looking for an experienced Senior CRA to support us with the following responsibilities in North Macedonia:

  • Conduct and report SIV, RMV, COV onsite monitoring visits
  • Perform CRF review, source document verification and query resolution
  • Be responsible for site communication and management
  • Be a point of contact for in-house support services and vendors
  • Communicate with internal project teams regarding study progress
  • Participate in feasibility research
  • Support regulatory team in preparing documents for study submissions
  • Prepare and participate in audits and inspections

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Independent on-site monitoring experience
  • Experience in all types of monitoring visits in Phase II and/or III
  • Full working proficiency in English and Macedonian is essential.
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Excellent communication, collaboration, and problem-solving skills
  • Ability to travel
  • Valid driver’s license

Additional Information

This is a great opportunity for you to further develop your skills, widen your therapeutic area experience, and become an expert in clinical research.

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