- Data entry
- Completion and return of CRF’s
- Data Queries
- Support monitoring visits, audits and inspections
- Arranging and collecting research patient’s notes for own and other research personnel’s use
- Liaising with other health professionals as required
- Maintaining / allocating appropriate copies of research documentation in patient hospital and research records
- Maintenance of study files to ICH GCP standards
- Support lead study clinician and other research professionals in-
- Documentation of adverse events in data source
- Investigator / study file set up and management
- Preparation of paperwork for Ethics committee and R&D approval
- Screening of patients
- Informed Consent documentation (according to local practice)
- Randomisation
- Completion and return of CRFs
- Data queries
- Documentation of adverse events in source data
- Investigator/Study file set up and management
- Support monitoring visits and audits and inspection
- Preparation of paperwork for Ethics committee/R&D
- Taking and shipping of trial related samples
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