Clinical Research Associate (CRA) *** UKRAINE*** officebased
DOCS Global
raine, UK, GB
5 днів тому
source : PharmiWeb.com

Description :

  • Participates in site feasibility and / or pre-trial site assessment visits, providing recommendation from local area about site / investigator selection in collaboration with the trial team
  • Acts as primary local company contact for assigned sites for specific trials.
  • Attends / participates in investigator meetings as needed.
  • Responsible for executing activities within site initiation and start-up, site monitoring, site management and site / study close-
  • out according to internal SOPs / WIs / IFUs and policies.

  • Ensures site staff is trained and the corresponding training records are complete and accurate at any time point during all trial phases.
  • Contributes to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
  • Ensures site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct.
  • Ensures that all AEs / SAEs / PQCs are reported within the required reporting timelines and documented as appropriate.
  • For AEs / SAEs, ensures that they are consistent with all data collected and with the information in the source documents.

  • Maintains complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS, eTMF / IF, Trial Master Source and Sharepoints). Profile :
  • A minimum of a BA / BS degree is required. A degree in a health or science related field is preferred.
  • Must have experience in Clinical Research or equivalent qualification
  • Usually 0-2 years' experience monitoring on site
  • Specific therapeutic area experience may be required depending on the position.
  • Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
  • Strong IT skills in appropriate software and company systems. Willingness to travel with occasional overnight stay away from home.
  • Proficient in speaking and writing the country language and English.
  • Good written and oral communication skills.
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