Quality Specialist

@ Johnson County Clintrials LLC

Position Summary

The Quality Specialist position serves as a subject matter expert in clinical research study policies, procedures, and processes. The role ensures accuracy, consistency, and compliance of source document templates (both paper and eSource) for multiple clinical trial sites. It requires alignment with SOPs, study protocols, case report form guidelines, sponsor requirements, and applicable regulations, ensuring that data collection tools are complete, accurate, and inspection ready before deployment.

This role collaborates with clinical operations 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 for accuracy and compliance.
• Ensure protocol required procedures, assessments, safety parameters, and visit schedules are accurately reflected.
• Verify consistency between source templates, case report forms, and sponsor provided documents.
• Identify gaps, discrepancies, or redundancies and provide actionable feedback.
• Collaborate confidently with CRIO/Site Integration staff and study personnel for corrections.
• Ensure adherence to FDA regulations, GDP (ALCOA+), ICH/GCP, HIPAA, OSHA, SOPs and protocol-specific requirements.
• Document review findings, track corrections and ensure timely approval using ASANA.
• Support standardization of template designs across studies and therapeutic areas.
• Contribute to development and maintenance of SOPs, checklists, workflows, and training materials.
• Participate in staff training and provide backup support within the team.
• Utilize the CTMS (Clinical Conductor) to track study activities and timelines.
• Perform additional duties as assigned.

Experience and Skills

• Subject matter expertise in study protocols, ICFs, case report forms, and sponsor documents.
• Proficiency in Microsoft Office Suite; experience with CTMS and eSource systems preferred.
• Excellent written, verbal, and interpersonal communication skills.
• Knowledge of medical terminology and clinical research concepts.
• Ability to work collaboratively and train/mentor peers.
• Ability to manage small projects independently and meet deadlines.
• Detail oriented with strong analytical and critical thinking skills.
• Capacity to respond to urgent team needs while ensuring compliance.

Physical Requirements

Must be able to sit, stand, walk, reach, and handle objects, with the ability to lift or move up to 20 pounds. Reasonable accommodations will be made for individuals with disabilities.

Education and Experience

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

Key skills/competency

Quality Specialist, clinical research, SOP, compliance, CTMS, eSource, FDA, ICH/GCP, data management, training