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Data Compliance Specialist
2 months ago
About Thermo Fisher Scientific
We are a leading provider of scientific instrumentation and software for a wide range of industries, including life sciences, healthcare, and environmental monitoring.
Job Summary
We are seeking a highly motivated and detail-oriented Data Compliance Coordinator to join our team in Hexham, United Kingdom. As a Data Compliance Coordinator, you will be responsible for ensuring the accuracy and integrity of data in our clinical trials.
Key Responsibilities
- Coordinate operational compliance activities on one or more studies to ensure successful delivery of the studies.
- Ensure accurate and timely entry of all data in the CRF from the source notes, and track the flow of the CRF's, queries, and patient recruitment statuses; report out the flow of data.
- Maintain ISF and study trackers as delegated.
- Follow the QC process and check that ICF's are correctly completed.
- Ensure that protocol visit windows are scheduled according to the protocol requirements and report deviations.
- QC all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flag any out of range values.
- Assist with archiving procedures if required.
- Assist monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
- Identify quality issues (QI) and report them, and apply CAPA reporting and root cause analyses.
- Prepare and collate regulatory documents for submission.
- Interpret and adhere to company SOP and COP, and assist with input during the review process.
- Adhere to the rules and regulations of ICH, GCP and other regulatory and ethical guidelines and data protection regulations.
- Assist with drafting compliance reports.
Requirements
- Fluent in English
- Good time management and multitasking skills in order to coordinate several studies with a number of participants simultaneously
- Appropriate MS Office Skills
- Good attention to detail
About Us
We are a company that values diversity, equity, and inclusion. We are committed to creating a workplace that is free from discrimination and harassment. We are an equal opportunities employer and welcome applications from all qualified candidates.
