2. Organise investigator’s start-up meeting and study site initiation meetings.
3. Coordinate the movement of laboratory samples and the resulting data when central laboratory facilities are used.
4. Ensure procedures are in place for appropriate optimisation of patients into the clinical trial.
5. Monitoring the assigned clinical trial following company SOPs and in accordance with GCP.
6. 6.Planning the requirements for clinical trial material, ordering clinical trial material (head office or local comparators), setting up and monitoring the systems whereby the Clinical Research Assistant can ship CT material to the investigator, maintaining procedures to account for the CT material, checking the expiration of CT material and requesting extensions if necessary.
7. Tracking completed CRFs and setting up systems whereby completed CRFs are rapidly entered into the database. Ensure that queries generated during cleaning are responded to in a timely fashion.
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