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Job Listings - USA

Clinical Trial Assistant
The purpose of this position is to assist the clinical project team in various in-house project related activities and maintain study documentation as per project instructions. In addition, to assist in other departmental activities as required.

The incumbent should be 1 – 3 years of experience in clinical research (Pharma or CRO) of with CRO/ Pharma/ Biotech/ Life Sciences Company.

The Core Responsibilities for the position would be:

IN-HOUSE SUPPORT
  • To provide project support to project team members for all the trial related activities.
  • To co-ordinate with the project team for different study related activities, issues, requests, meetings.
  • To assist the project lead in study related activities.
  • To prepare and ship study related materials.
  • To co-ordinate with third parties like courier and translating agencies.
  • To receive administrative documents and, check them for completeness and accuracy.

DOCUMENTATION
  • To prepare, maintain and update the in-house trial related files according to SOPs and ICH GCP.
  • To review in–house study files, proactively identify missing documents and bring it to the notice of all concerned.
  • To co-ordinate with ethics committee submissions and prepare site specific dossiers.
  • To assist the project managers in preparation and submission of regulatory documents.