QC Specialist

The Role

• Supports Clinical Manager to ensure data integrity during study set up and data collection
• Timely reviews source data collected for data integrity and compliance with Good Documentation Practices and relevant SOPs
• Reconciles source data collected on paper with eSource comments and entries
• Works with the clinic and project management departments to ensure that qc and query resolution timelines are being met
• Works with Clinical Manager to implement measures to uphold data integrity
• Complies & adheres to GCP guidelines and regulations as required of this role.
• Ensures study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards.
• Ensures subject safety at all times

• Serves as support for Clinical Manager to ensure studies are set up for successful and high-quality data collection
• Understands clinical protocols and requirements for data collection
• Performs real-time QC checks on critical data as assigned by Clinical Manager
• Ensures proper QC checks are performed on all clinical data for data integrity, particularly looking for incomplete or implausible data
• Resolves queries as per scope and coordinates resolution of queries requiring other clinical parties
• Ensures queries are addressed and resolved by the appropriate parties; assists as needed
• Identifies discrepancies in source documentation and works with clinical staff for corrections and/or explanations.
• Promptly reports any evidence or suspicion of fraudulent data collection or documentation
• Evaluates query responses in eSource. May reissue query as necessary and re-train staff as appropriate
• Reports/records protocol deviations encountered during review of clinical data
• Ensures paper sources are transcribed appropriately and timely into the eSource capture system
• Assists with QC of study activity schedules against the eSource build during study start up
• Prepares the initial template for lab tracking and ensures lab tracking is up to date.
• Works collaboratively with the Clinical Leads during study start up to plans for high quality data collection for all studies
• Works with the Project Management team to ensure the timelines are being met for QC and query resolution
• Assists with retrospective review of clinical data, e.g. in quality deviation investigations, upcoming audits, etc.
• Assists with activities to support validation of clinical systems
• Acts as a recorder for clinical activities in eSource as required
• Performs clinical activities according to scope of practice

• Minimum 2 years’ relevant experience in a clinical environment or equivalent experience in another role
• Proficient in the use of Microsoft Office packages including Word, Excel...etc.
• Attention to detail and organizational skills required
• Able to assume increasing levels of responsibility and perform effectively
• Able to plan, coordinate, organize, and prioritize to meet deadlines
• Able to interact successfully with team members and study participants
• Self-directed - able to perform with minimal supervision
• Able to read and understand protocols

The job may involve the following:

• Very high concentration of work
• Strict and tight deadlines
• Having to juggle a range of tasks/issues simultaneously
• Working outside normal business hours