Quality Specialist

Quality Specialist Position Summary: The Quality Specialist position serves as a subject matter expert in the policies, procedures, and processes of clinical research studies. This position ensures the accuracy, consistency, and compliance of source document templates (paper and eSource) developed for multiple clinical trial sites. This role verifies templates align with SOPs, study protocols, case report forms guidelines, sponsor

Requirements

and applicable regulations, ensuring data collection tools are complete, accurate, and inspection ready before deployment. The Quality Specialist works closely with clinical operation teams including data management and CRIO/Site Integration staff to ensure high-quality study documentation and supports continuous improvement of source development processes. Additional

Responsibilities

include staff training and cross-coverage within the Quality Department. The Quality Specialist reports to the Chief Quality Officer. Position

Responsibilities

: Review draft source document templates paper records and eSource (CRIO) for accuracy, completeness, and compliance with study protocols, CRF completion guidelines, SOPs and sponsor

Requirements

e.

intake forms, visit worksheets, treatment histories, medical histories, clinical notes, laboratory results, ECG interpretations, medical records, adverse event reports, deviation logs, equipment logs, processing logs, and IP administration logs) Ensure consistency between source templates and corresponding case report forms and sponsor provided documents Identify gaps, discrepancies or redundancies in draft templates and provides clear, actionable feedback Ensure appropriate corrections are made through confident, knowledge-based collaboration with CRIO/Site Integration staff, investigators, coordinators, regulatory staff and other study personnel Verify source document adherence to FDA regulations, GDP (ALCOA+), ICH/GCP, HIPAA, OSHA, SOPs and protocol-specific

Requirements

Document review findings, track corrections and ensure timely approval and release of final source templates using ASANA Support standardization of source template design across studies and therapeutic areas Contribute to the development and maintenance of SOPs, checklists, workflows, and training materials for template review Participate in ongoing staff training and development Crosstrain in other Quality Specialist (QA/QC) functions and provide backup support to quality colleagues as needed Use the site CTMS (Clinical Conductor) to track study activities and timelines Perform other duties as assigned ATS provider: Paylocity.