Clinical Data Specialist

Clinical Data Specialist

The Clinical Data Specialist is responsible for the review of all source data and ensure all applicable data is entered into its respective database and / or Case Report Form (CRF). Ensure the completeness, accuracy, and consistency of source data and CRF data entry so that it meets the standard of quality expected for reporting to Sponsors and regulatory bodies. Participate with auxiliary teams involved in study set up, conduct, and data cleaning of clinical trials.

Essential Functions :

• Attend study setup meetings to determine QC criteria and timelines for each study
• Review study-specific source documents to ensure all forms are accurate prior to study start and that all data collected is in accordance with study-specific Case Report Forms and protocol requirements.
• Ensure QC reviews are complete in accordance with study-specific timelines
• Review source data on an ongoing basis to ensure the following : Clinical source data is complete according to GCP and FDA guidelines, protocol deviations (if applicable) are documented, and source data is collected in accordance with Sponsor requirements, and Celerion SOPs / PGs.
• Ensure data corrections are completed according to GCP guidelines, and Celerion SOPs / PGs.
• Complete a Final QC to ensure all source data is accounted for and has been QC reviewed.
• Perform accurate data entry and verification for Celerion Standard and Sponsor Provided EDCs.
• Archive source documentation including CRFs.
• Complete QC / DE dedicated milestones in a timely manner.
• Perform standard quality control steps.

Requirements :

PI752bf8725be9-30511-38904849