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Clinical Research Associate II

Role overview

Summary

This role is for a Clinical Research Associate II at PSI, a Contract Research Organization. You will be involved in monitoring clinical studies across various therapeutic indications, ensuring high-quality standards and effective communication with site teams and internal project groups.

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience.
  • Independent on-site monitoring experience Argentina
  • Experience in all types of monitoring visits in Phase II / III
  • Full working proficiency in English and Spanish
  • Proficiency in MS Office applications

Responsibilities

  • Conduct and report all types of onsite monitoring visits
  • Perform CRF review, source document verification and query resolution
  • Be responsible for site communication and management
  • Support regulatory team in preparing documents for study submissions

Key facts

Hard skills

Other skills

  • Microsoft Office
  • Communication
  • Collaboration
  • Problem Solving
  • Teamwork
  • Planning

About the company

PSI CRO AG  logo

PSI CRO AG

  • Clinical Research (CRO)
  • Large
  • 1,001–5,000
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com

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Job description

Company Description

PSI is a leading Contract Research Organization with more than 25 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 Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.

You will:

  • Conduct and report all types of onsite monitoring visits
  • Be involved in study startup and feasibility research
  • 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
  • Support regulatory team in preparing documents for study submissions

Qualifications

  • College/University degree in Life Sciences or an equivalent combination of education, training & experience
  • Independent on-site monitoring experience Argentina
  • Experience in all types of monitoring visits in Phase II / III
  • Experience in Oncology is preferred
  • Full working proficiency in English and Spanish
  • Proficiency in MS Office applications
  • Ability to plan and work in a dynamic team environment
  • Communication, collaboration, and problem-solving skills
  • Ability to travel

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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