Quality Specialist

Description

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
• Confirm that all protocol required procedures, assessments, safety parameters, and visit schedules are accurately reflected in the source templates (i.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
  
  

Requirements

Experience and Skills:

• Subject matter expertise in study protocols, ICFs, case report forms and sponsor-provided documents
• Proficiency in Microsoft Office Suite, experience with CTMS and eSource systems strongly preferred
• Excellent written, verbal and interpersonal communication skills
• Knowledge of medical terminology and clinical research concepts
• Effective team collaboration with ability to train and mentor peers
• Ability to manage small projects independently
• Self-motivated, results-oriented, and deadline driven
• Strong organizational skills with the ability to prioritize and manage multiple projects
• Demonstrated attention to detail and accuracy
• Strong analytical and critical thinking skills
• Ability to respond to urgent team needs while maintaining accuracy and compliance
  
  

Physical Requirements

The physical demands described here are representative of those that must be met to successfully perform the essential functions of the job. Reasonable accommodation may be made to enable individuals with disabilities.

• Ability to sit, stand, walk, reach with hands and arms, and use hands along with fingers, to handle or feel
• Ability to lift and/or move up to 20 pounds
  
  

Education And Experience

• Bachelor’s degree in life sciences or related field
• Minimum of 2 years’ experience in clinical research, preferably in QA/QC, data management, regulatory or monitoring
• Basic understanding of regulations governing clinical research (CFR, GCP, HIPAA)
• Experience in CTMS (Clinical Conductor) and eSource (CRIO) a plus