Description
Main responsibilities (to include but not limited to):* Investigator identification and selection.
* Co-ordination of ethics committee and regulatory authority applications and approvals.
* Pre trial procedures including collation of necessary documentation.
* Organisation, attendance and/or presentations at investigator meetings.
* Initiation, monitoring and close-out of investigational sites
* Training of site staff to trial specific and industry standards.
* Supervision and/or distribution of trial supplies, including the trial drug (investigational medicinal product).
* Protocol and Case Report Form (CRF) development.
* Archiving of trial documentation and correspondence.
* Clinical Trial Report and manuscript for publication (occasional).