Clinical Research Data Coordinator

3 weeks ago


Hexham, Northumberland, United Kingdom Thermo Fisher Scientific Full time

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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