QA Specialist is responsible for ensuring compliance with protocols, federal regulations, industry guidelines and company procedures. Maintain knowledge of Good Clinical Practices (GCP), Standard Operating Procedures (SOP), and Federal and applicable regulations.
- Performs review of protocols, informed consents, and case reports forms (CRFs) prior to study initiation and revised documents
- Works directly with international coordinators and project managers to ensure accurate documentation is performed for clients
- Performs review of marketing and recruiting documentation
- Performs audit of study material receipt and return/destruction
- Performs in clinic audit of study procedures
- Conducts audits of clinical trial master files, source data, and procedures for protocol, monitoring plan (when applicable) SOP, and GCP/ICH compliance
- Performs review of Final Report
- Assists with auditing the company training files
- Monitors internal studies and alternative sites
- Assist with documentation of non-conformities, corrective actions, and preventive actions
- Critical in training of new departmental staff
- Other duties or tasks assigned by manager
- Work with all involved parties to ensure that both the equipment and operational needs are met.
- Oversee that the lab safety and orderly contact and take prompt corrective action when unsafe conditions, practices, or equipment are reported or observed.
- Encourage prompt reporting of health and safety concerns.