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Clinical Research Associate II (Contract)

  • PSI CRO
  • Lisbon, Portugal
  • €35,000 – €45,000

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 Clinical Research Associate 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.

Skills

  • Clinical Trial Monitoring
  • Source Document Verification
  • ICH-GCP Guidelines
  • Regulatory Compliance
  • Site Management
  • CRF Review
  • Feasibility Studies

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