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PSI CRO

CRA II (Contract based)

Posted 24 days ago
2-5 years experience
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AI Summary

The CRA II will conduct onsite monitoring visits, manage site communications, and ensure data quality and compliance with clinical research standards. They will also support study startup activities, regulatory submissions, and oversee project timelines and site relationships.

Company Description

PSI is a leading Contract Research Organization with more than 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees.  We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

As a Contract CRA II, you will work on the frontline of communication with project stakeholders, ensuring timelines, targets and standards of clinical research projects in a variety of therapeutic indications.  You will build and maintain relationships with clinical sites and investigators. You will focus on subjects’ rights, safety and well-being and quality of data compliance.

Home-based (freelance)

You will:

  • Conduct and report all types of onsite monitoring visits
  • Be involved in study startup 
  • Perform CRF review, source document verification and query resolution
  • Be responsible for site communication and management
  • Supervise study activities, timelines, and schedules on the country level
  • Be a point of contact for in-house support services and vendors
  • Be involved in quality control, such as compliance monitoring and reports review
  • Participate in feasibility research
  • Support regulatory team in preparing documents for study submissions

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • A minimum of 1 year of independent on-site monitoring experience in Portugal
  • Experience in all types of monitoring visits in Phase II and/or III
  • Experience in IBD/Inflammatory Bowel Diseases is mandatory
  • Full working proficiency in English and Portuguese 
  • Proficiency in MS Office applications
  • Ability to plan, multitask and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel

Additional Information

Make the right call and take your career to a whole new level.  Join the company that focuses on its people and invests in their professional development and success.

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