Clinical Research Associate

EastHORN Clinical Services

Clinical Research Associate

EastHORN Clinical Services

Poland

EastHORN Clinical Services in CEE Ltd is a clinical contract research organisation (CRO) serving global pharmaceutical and biotechnology companies in the development of new medicines. The company has operations throughout Central and Eastern Europe. Since starting 15 years ago, we have grown and have established operations in 25 countries.

Our international clients value our enthusiastic and flexible approach to meeting their needs and we are growing rapidly. To support our further growth, we are looking for a Clinical Research Associate, based in Poland.

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 Clinical Operations Manager, you will be a key member of the Clinical Operations team in Poland.

We are searching for an experienced, ambitious and energetic person, able to undertake challenges 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 assists efficiently in query management process and IP accountability and reconciliation;
  • Completes monitoring trip reports, reports study progress, escalates issues related to the protocol, and ensures 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;
  • Provides feedback and supports during appraisal process, performing co-monitoring visits;
  • Review and development (at request) of study essential documents;
  • Acts in Lead role on a project, assuming additional responsibilities as retailed by Line Management;
  • Assists in business development when appropriate.

Competencies required:

  • Minimum 2 years of independent monitoring experience;
  • Life sciences background is required;
  • University Degree in Medicine 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;
  • Ability to work and to take proper decisions under presure;
  • Flexibility to travel;
  • Cost effective abilities;
  • Excellent written and oral communication skills in Polish and English;
  • Social and soft skills.

Benefits:

  • Working in experienced and very professional team;
  • Possibility to grow within the company;
  • Flexible approach to work time;
  • Car allowance;
  • Competative remuneration;
  • Eligibility to bonus scheme twice per year.

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© EuroJobsites 2019

EuroJobsites is a UK registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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