Job summary:

As an experienced Clinical Research Associate you will be expected to actively participate in and manage the recruitment of potential investigators. You will be responsible for monitoring of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, liaison with vendors and other duties. You will function as the primary contact for sites regarding regulatory compliance and protocol questions and communicate with clinical sites on an ongoing basis to address and resolve issues. Reporting to the Senior Clinical Operations Manager, you will be a key member of the Clinical Operations team in Georgia.

We are searching for an experienced, ambitious and energetic person, able to undertake chal- lenges in the project, push forward development of the project and function well in the project team. The desired person shall be open to cross cultures communication and cooperation and shall be significantly independent in their performance.

Main Tasks include, but are not limited to:

  •   Performs investigator identification and site selection and conducts pre-study visits for qualification of investigators and sites
  •   Prepares and facilitates site training and initiation
  •   Verifies clinical data against source document during routine monitoring and assist ef-

    ficiently in query management process and IP accountability and reconciliation.

  •   Completes monitoring trip reports, reporting study progress, escalating issues related to the protocol, and ensuring patient safety and ICH/GCP compliance within

    EastHORN and/or Sponsor timelines and quality

  •   Ensures all site queries are resolved and recorded in a timely manner
  •   Organizes translation and provides final approval of study documents, as required
  •   Manages adverse event reporting and follow up
  •   Prepares and negotiates study budgets and contracts for the site, investigator, and study

    vendors and assists in obtaining contract signatures

  •   Prepares, organizes, and oversees site, investigator, and vendor payments
  •   Review and development (at request) of study essential documents
  •   Assists in business development when appropriate

Competencies

  • Minimum 2 years of independent monitoring experience
  • Life sciences background is required
  • University Degree in Medicine is an advantage
  • Experience in Oncology is an advantage
  • Excellent knowledge of the clinical trial process and ICH/GCP guidelines
  • Experience with Electronic Data Capture is required
  • Excellent organizational and time management skills to handle multiple

    priorities

  • Leadership skills
  • Ability to work and to take proper decisions under presure
  • Flexibility to travel
  • Cost effective abilities
  • Excellent written and oral communication skills in Georgian and English
  • Social and soft skills

Benefits:

  • –  Working in experienced and very professional team
  • –  Possibility for development and training
  • –  Flexible approach to work time
  • –  Competative remuneration
  • –  Eligible to the Bonus scheme available in the company

    If you are a reliable and positive personality and would like to contribute to the further success of a dynamic young company in a growing market, please send your CV and motivation letter in English to:

    careers@easthorn.eu