CRA/ Clinical research associate (oncology)

Новосибирск

Responsibilities:

  • Conducts site qualification, initiation, interim monitoring and study closeout visits f in accordance with applicable regulations, GCPs, SOPs etc.
  • Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives.
  • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
  • Ensures safety and protection of study subjects through compliance.
  • Trains study site personnel on the protocol
  • Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis.
Qualifictions:
  • Minimum 6 months in clinical research monitoring. Experience in on­site monitoring of investigational drug or device trials is required
  • Experience as CRA II-III phases will be an advantage
  • Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
  • Readiness for business trips
  • English knowledge - starting from Intermediate
Terms:
  • Salary will be discussed individually
  • All necessary benefits

1 сентября 2021
3 сентября 2021
От 1 года до 3 лет

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