Senior Clinical Research Associate

CLINICAL CONSULTING sp. z o.o.O firmie

  • mazowieckie

  • Ogłoszenie wygasło 24 dni temu
  • Praca zdalna
  • Umowa o pracę
  • Pełny etat
  • Specjalista

CLINICAL CONSULTING sp. z o.o.

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.

Senior Clinical Research Associate

ESSENTIAL JOB FUNCTIONS

  • 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

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

BENEFITS

  • Attractive salary 
  • Home based job 
  • Private medical healthcare 
  • Flexible organisation - team based approach 
  • Personal growth and development opportunities in a global environment
  • Company car


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.

Senior Clinical Research Associate

ESSENTIAL JOB FUNCTIONS

  • 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

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
2 - 4 lat

BENEFITS

  • Attractive salary 
  • Home based job 
  • Private medical healthcare 
  • Flexible organisation - team based approach 
  • Personal growth and development opportunities in a global environment
  • Company car

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