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Freelance Clinical Research Manager

7 dni temu

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Overview

Rho is a global contract research organization (CRO) dedicated to healthcare and clinical research. We take a personalized approach to working with our clients, understanding their unique needs and challenges.

We are seeking a highly skilled Freelance Regional Clinical Trial Coordinator to join our team in Poland, Estonia, Lithuania, or Latvia. As a member of our Clinical Operations team, you will have the opportunity to work on exciting projects and contribute to the growth and success of our company.

The ideal candidate will have excellent organizational, communication, and teamwork skills, as well as strong attention to detail and computer literacy. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply.

Responsibilities
  • Preparation of ISFs (Investigator Site Files) in collaboration with the Trial Manager.
  • Effective communication and coordination with CRA and sites as instructed by the Trial Manager.
  • Maintenance of TMF (Trial Master File) or CRO Project File, ensuring accuracy and completeness through regular review.
  • Timely upload of Country and Site level documents in Veeva Vault.
  • Transfer of Study documents to Sponsor, as agreed, on an ongoing basis.
  • Support for preparation of documents package for submission to CA (Competent Authorities) and EC (Ethics Committee).
  • Facilitating communication between stakeholders regarding documentation management.
  • Providing support to stakeholders on trial record planning, collection, filing, confirmation, and archiving.
  • Sponsor/Rho team meetings preparation, drafting meeting minutes.
  • Maintenance of tracking information for Study activities.
  • Support for Trial Manager on data entry and maintenance to systems.
  • Support for CRA in maintaining ISF at Site.
  • Support for sites getting access to systems, as needed.
  • Sharing updates with sites as required.
  • Support for audits and/or inspections.