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Clinical Research Associate

CLINICAL CONSULTING sp. z o.o.

  • Lesser Poland

    Lesser Poland
  • offer expired over a month ago
  • contract of employment
  • full-time
  • specialist (Mid / Regular)
  • home office work
  • Immediate employment
  • More than one vacancy
  • remote recruitment

Your responsibilities

  • Responsible for the monitoring of clinical trials and tracking study progress for our clients

  • Collect study related data and assist with the preparation, review and submission of regulatory documents to regulatory authorities

  • Contribute to the overall management of trials in accordance with ICH-GCP standards, local requirements and SOPs

  • Start-up, maintenance and closure activities of clinical studies including the maintenance of the TMF and study documentation

  • Monitor on-site clinical trials in accordance with Clinical Consulting and/or client company Standard Operating Procedures, FDA regulations, and GCP and ICH guidelines

  • Review CRFs (paper or electronic) and subject source documentation for validity and accuracy and generate queries to investigational sites/clients to resolve problem data

  • Set up ISF and SMF (or cooperate with CTA) and distribute to the investigational sites.

  • Update CTMS system with site and study information

  • May assist in the preparation of study documentation such as CRF Completion Guidelines, patient diaries, study participation cards by reviewing for accuracy and completeness

Our requirements

  • Bachelor’s Degree, preferably in life science or nursing; or equivalent

  • Minimum 2 years of relevant clinical experience

  • Knowledge of medical/scientific terminology

  • Readiness and ability to learn new skills as required by the position

  • Excellent attention to detail

  • Solid knowledge of Good Clinical Practice (GCP) requirements

  • Excellent organizational skills Knowledge of the governance and legislative requirements relating to the conduct of clinical research in Poland

  • Knowledge of electronic data capture systems and the data management process in clinical studies

What we offer

  • Attractive salary

  • Home based job

  • Private medical healthcare

  • Flexible organisation - team based approach

  • Personal growth and development opportunities in a global environment

  • Company car

About Us

CLINICAL CONSULTING is a Regional CRO headquartered in Poland. We believe that “Global in mind and local at heart” is the core of our success.

At CLINICAL CONSULTING , you will be offered the possibility to develop in a global environment with a company culture distinguished by passion, innovation and talent.