Quality Control 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 Main Tasks and Responsibilities 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 The Candidate 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 Job Demands 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 #J-18808-Ljbffr