Clinical Research Quality Control Specialist

Quality Control Specialist - Clinical Trials Key Responsibilities

• Demonstrate exceptional attention to detail, organization, and accountability while managing multiple priorities in a fast-paced clinical research environment.
• Independently review and interpret study protocols, amendments, investigator brochures, and study manuals to ensure accurate application of study requirements.
• Perform quality control (QC) review of clinical data across multiple protocols and therapeutic areas, including concurrent enrolling studies.
• Conduct thorough review of medical records, source documents, and study charts in collaboration with Investigators and site staff to ensure data integrity and protocol compliance.
• Complete accurate and timely data review within electronic data capture (EDC) systems (e.g., Inform, Medidata Rave, Veeva Vault).
• Ensure adherence to sponsor and study timelines for data entry, query resolution, and database updates in accordance with SRA or sponsor expectations.
• Perform routine and targeted quality assurance checks to verify that study processes and data meet protocol, GCP, and regulatory standards.
• Identify, document, and elevate data discrepancies, deviations, and quality issues; support root cause analysis and corrective and preventive actions (CAPA).
• Analyze data trends and patterns to identify opportunities for process improvement and enhanced data quality.
• Collaborate cross-functionally with study coordinators, investigators, monitors, and sponsors to resolve data queries and quality concerns efficiently.
• Support and coordinate monitoring visits, audits, and inspections, ensuring all required documentation is accurate, complete, and audit‑ready.
• Respond to and help resolve data queries generated by monitors, auditors, or other reviewers in a timely and effective manner.
• Maintain accurate and comprehensive documentation of QC activities, findings, and resolutions.
• Provide administrative and clerical support, including order entry and study-related documentation tasks as needed.
• Communicate professionally and effectively with internal teams, sponsors, CROs, and external vendors.

• Strong organizational skills with the ability to prioritize tasks and meet deadlines.
• Proficient in data collection, analysis, and reporting using tools such as Excel and pivot tables.
• Attention to detail and a high level of accuracy in transcribing information.
• Basic math skills for performing calculations related to quality assurance.
• Excellent communication skills, both written and verbal.
• Proficient in Microsoft Office suite (Word, Excel, PowerPoint).
• Previous experience in quality assurance or related role is preferred.