Quality Control Assistant [Temporary Student Contract]

Job description

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. This is a great opportunity for students to gain experience in the world of clinical trials. This is a 12-month, part-time contract: 16 hours per week (+25%). 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