Clinical Research Data Coordinator
3 weeks ago
Clinical Research Data Coordinator
At Thermo Fisher Scientific, we're dedicated to enabling our customers to make the world healthier, cleaner, and safer.
As a Clinical Research Data Coordinator, you'll play a critical role in ensuring the accuracy and integrity of our clinical trial data.
Your key responsibilities will include:
- Coordinating operational compliance activities on one or more studies to ensure successful delivery of the studies.
- Ensuring accurate and timely entry of all data in the CRF from the source notes, and tracking the flow of the CRFs, queries, and patient recruitment statuses; reporting out the flow of data.
- Maintaining ISF and study trackers as delegated.
- Following the QC process and checking that ICFs are correctly completed.
- Ensuring that protocol visit windows are scheduled according to the protocol requirements and reporting deviations.
- QCing all supporting reports (laboratory reports/GP SDV/Consultant) to ensure they are reviewed and signed off by a physician within the appropriate timelines and flagging any out-of-range values.
- Assisting with archiving procedures if required.
- Assisting monitors, sponsor representatives with the preparation of monitoring visits and query resolutions during monitoring visits.
- Identifying quality issues (QI) and reporting them, and applying CAPA reporting and root cause analyses.
- Preparing and collating regulatory documents for submission.
- Interpreting and adhering to company SOP and COP, and assisting with input during the review process.
- Adhering to the rules and regulations of ICH, GCP, and other regulatory and ethical guidelines and data protection regulations.
- Assisting with drafting compliance reports.
To be considered for this exciting opportunity, you will require:
- 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.
At Thermo Fisher Scientific, we're committed to creating a workplace that's inclusive, diverse, and rewarding.
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