Responsible for reviewing of all study related documentation to ensure the quality, reliability, accuracy, completeness, and consistency according to Protocol, SOPs and Regulatory requirements.
- Review study files after completion and ensure that they are accurate and legible according to Protocol , SOPs and Regulations
- Ensure all prepared study source documents and/or Forms are in accordance to protocols SOPs and Regulations
- Observe, on the random basis, clinical procedures during the conduct of studies, sample bundling and shipping process
- Provide reports of the reviewed data to relevant personnel/department
- Perform other duties as assigned by supervisor
- A minimum of a post-secondary degree or diploma in a sciences or healthcare related discipline.
- Knowledge of research principles, ICH/GCP guidelines and applicable regulations
- Demonstrated experience with MS office (Word, Excel, Outlook, PowerPoint)
- Excellent interpersonal, verbal and written communication skills
- Ability to work effectively and efficiently in a fast paced, multitasking environment
- Detail oriented with effective decision making and problem solving skills
- Ability to work flexible hours both day and evening shifts including weekends and evenings.
- 1-2 years previous clinical research experience in CRO/pharmaceutical industry required