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Clinical Research Associate II (Contract based)

🕒 2 days ago
📍 🇵🇹 Portugal - Remote🎹 Mid-level🧫 Clinical Research Specialist📢 🇬🇧 English Required📢 🇧🇷🇵🇹 Portuguese Required⏳ Temporary/Contract
Clinical Site MonitoringStudy StartupCRF ReviewSource Document Verification
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📜 Description

  • Conduct and report onsite monitoring visits across clinical studies.
  • Support study startup, feasibility research, and regulatory submission preparation.
  • Review CRFs and source documents, and resolve data queries.
  • Manage site communications and relationships with investigators.
  • Oversee country-level study activities, timelines, and schedules.
  • Coordinate with in-house support teams and vendors, and contribute to quality control.

🛠️ Requirements

  • 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
  • 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
Full job description

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
  • 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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