Quality Control Associate; Part-time

The Quality Control (QC) Associate is responsible for reviewing, identifying and assists in addressing staff Good Documentation Practice issues, study information discrepancies, and SOP and Study Protocol deviations. The QC Associate reviews study source documents ensuring compliance with the protocol and ensures potential Quality Issues are identified and reported immediately to QA. This role also assists in preparing study related documents prior to study participant visits, internal, or third-party audits, and monitoring visits.

The QC Associate provides feedback to the team as needed on QC findings and trends, recommends the need for clinical trial staff training/re‑training, and ensures that Corrective Action Preventive Action processes are observed and implemented.

• Reviews study files after completion and ensures that they are accurate and legible according to specific protocols, SOPs, and regulations
• Ensures all prepared study source documents and/or forms are in accordance with protocols, SOPs, and applicable regulations
• Reviews all completed study related documentation, including study source documents, medical screening files, and non‑study specific site documentation
• Reviews “live” and all completed study related documentation, including but not limited to:
• QC of source to CRF Transcription
• Medical screening files
• Works closely with CRCs to ensure studies are conducted properly with high quality and high efficiency
• Observes on a random basis, clinical procedures during the conduct of studies, including sample sorting and shipping processes to ensure compliance with documented practices
• Provides QC reports of the reviewed study data to relevant site staff
• Performs other tasks and projects as assigned
• Develops and utilizes QC Checklists or other QC tools designed to document the QC review process
• Assists with training of new QC Data Reviewer Staff
• Participates in review of SOPs and study protocols
• Addresses day‑to‑day QC issues and escalates issues as appropriate
• Prepares for and participates in regulatory inspections, sponsor or internal QA audits and monitoring visits
• Provides accurate and timely study QC status updates to the Clinic In‑Charge and Lead CRCs
• Collaborates within and between teams during process improvement exercises, SOP creation and/or revision, internal and external meetings, and other company‑related initiatives and goals
• Accommodates flexible schedule (available days, afternoons, nights, and weekends)
• Minimal travel may be required (up to 25%)
• Other duties as may be required and as training and experience allow
• Promotes GXP compliance across the organization
• Maintains an attitude and philosophy consistent with the Company standards

• Knowledge of the methodology related to the conduct and monitoring of clinical trials per ICH E6 guidelines and per Part C, Division 5 of the Health Canada Food and Drug regulations
• Understands care of study participants, aspects of human subject protection and safety
• Knowledge of Pharmaceutical and Natural Health Product Regulations
• Strong verbal and written communication skills in English (spoken and written)
• Practices leadership and professionalism skills as well as understanding the importance of teamwork necessary for conducting a clinical trial.
• Takes pride in accomplished task and observes accountability and ownership
• Is organized, efficient, focused and has a high attention for detail
• Proficient in MS Office, Excel, and Power Point
• Good presentation skills are considered an advantage, but are not required

• A minimum of a BA/BSc degree is required; a degree in a health, science, or related field is preferred
• At least 1 year of clinical trial experience or equivalent, based on qualifications and training in a Phase 1 research unit or similar research facility preferred; specific therapeutic area experience is an asset for the position
• CCRP accreditation or similar clinical designation is an asset