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    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