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
The incumbent should be 1 – 3 years of experience in clinical research (Pharma or CRO) of with CRO/ Pharma/ Biotech/ Life
The Core Responsibilities for the position would be:
- 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.
- 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.