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

Check Informed Consent Forms for completeness and compliance
Corrections done according to GCP and Good Documentation Practice (GDocP) guidelines
Check In/ Exclusion criteria according to protocol requirements
Control of assessment performance according to protocol specifications
Control of source data in timely manner to ensure accuracy and completeness
Check of data regarding completion and plausibility
Check of source data against database for consistency and accuracy
Control of Adverse Event / Concomitant Medication documentation
Data entry from ClinBase® and source data to paper- / e-CRF
Check of ClinBase® and source data versus paper- / e-CRF entries
Other tasks in the opinion of the manager and as required by the EPCU Operations

Skills

English language knowledge
Communication skills
Computer skills (Windows Office)

Knowledge And Experience

Experience in data transcription, data validation or data processing preferred

Education

Medical or Scientific University education preferred

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