Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion offers one of the most experienced clinical pharmacology research networks in the industry.
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Purpose:
As a Quality Control Specialist you are responsible for the review and verification of all source data. Conduct data reconciliation and final check of data. Conducts final quality check and reviews source documentation. Ensures the completeness, accuracy and consistency of source data so that it meets the standards of quality expected for reporting to Sponsors and regulatory bodies. Participate with multidisciplinary teams involved in setting up, conducting and reporting clinical trials.
Essential Functions:
For all assigned studies, ensure the following:
- Attend internal study initiation meeting and meet with Clinical Data Manager (CDM) and Clinical Study Manager (CSM) to determine Quality Control (QC) criteria and timelines for each study
- Ensure QC reviews are completed in accordance with study specific timelines
- Ensure consistent and complete review of source data by completing a Study Information Document indicating all study specific QC review requirements
- Meet with CDM and CSM to review any study specific source data forms prior to study start to ensure completion, accuracy, and ability to capture study information required to complete the study specific CRFs and required by the study protocol and Celerion SOPs/PGs
- Prepare and manage study materials including but not limited to Source Data Storage Binder /Files
- Review source data on an ongoing basis to ensure the following:
- Medical history and ICF data is complete according to GCP and FDA guidelines and all subjects meet study eligibility criteria according to the study protocol
- 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
- All deviations and documentation errors are sent to clinical staff for correction and updates as applicable
- 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
- Compile and sort all screening failures – not on study (NOS) – data
- Archive study source documents (as needed)
Full time position. Day shift hours Monday – Friday
Source: Indeed.com
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