Supports data entry to the clinical trial process. Helps ensure all study documentation and source data is captured accurately in eCRF, up to date and first time right. Assists with quality reviews and answers any eCRF queries for studies with low complexity in a timely manner.
• Maintains ISF and study trackers as delegated and supports the verification that ICFs are correctly completed.
• Assists with data capturing activities on one or more studies. May provide support across multiple sites and/or regions.
• Ensures accurate and timely entry of all data in the eCRF from the source notes and helps track the flow of the eCRFs and queries.
• Assists with the verification that protocol visit windows are correct according to the protocol requirements and reports deviations.
• May assist monitors and sponsor representatives with query resolutions after monitoring visits. Escalates to management as needed.
• Learns and adheres to company SOP and COP and assists with input during the review process.
• Adheres to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
• Assists with drafting compliance reports.
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to at least 2 years).
Knowledge, Skills and Abilities:
• Ability to multi-task and support multiples studies with a number of participants simultaneously
• Good interpersonal skills
• Good working knowledge of Business English
• Basic MS Office and computer skills
• Ability to learn basic medical terminology
• Good attention to detail