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The Quality Control Assistant is responsible for quality control, transcription and clarification of data collected during study conduct within the Early Phase Clinical Unit. This role ensures data accuracy, completeness, and compliance with Good Clinical Practice (GCP) guidelines and study protocols through systematic review of clinical documentation, and accurate data entry into electronic and paper Case Report Forms.
The successful candidate will have availability as follows; Students [16 hours per week (+25%) ] and Temporary Workers minimum 20 hours per week.
Key Accountabilities:
1. Check Informed Consent Forms for completeness and compliance
2. Corrections done according to GCP and Good Documentation Practice (GDocP) guidelines
3. Check In/ Exclusion criteria according to protocol requirements
4. Control of assessment performance according to protocol specifications
5. Control of source data in timely manner to ensure accuracy and completeness
6. Check of data regarding completion and plausibility
7. Check of source data against database for consistency and accuracy
8. Control of Adverse Event / Concomitant Medication documentation
9. Data entry from ClinBase® and source data to paper- / e-CRF
10. Check of ClinBase® and source data versus paper- / e-CRF entries
11. Other tasks in the opinion of the manager and as required by the EPCU Operations
Skills:
12. English language knowledge
13. Communication skills
14. Computer skills (Windows Office)
Knowledge and Experience:
15. Experience in data transcription, data validation or data processing preferred
Education:
16. Medical or Scientific University education preferred