Role Description

The Clinical Quality Specialist provides hands-on support to the Clinical Quality function and broader Clinical Operations team to ensure compliance with Good Clinical Practice (GCP), internal procedures, and applicable regulatory requirements. This role partners closely with the Director of Clinical Quality to support the maintenance and continuous improvement of the Quality Management System (QMS), execution of the clinical audit program, and development of clinical SOPs and training initiatives. This is a mid-level role requiring prior clinical trial experience and the ability to operate independently with strong organization, sound judgment, and attention to detail. This is a remote position.

Requirements

• Support the maintenance and continuous improvement of the Clinical Quality Management System (QMS)
• Assist with SOP creation, revision, formatting, and document lifecycle management
• Track and support CAPA development, follow-up, and closure activities
• Assist in planning and execution of internal and external audits
• Support audit documentation and inspection readiness activities
• Partner with Clinical Operations to ensure quality oversight across clinical trials
• Support development of clinical processes, tools, and study documentation
• Assist with development and delivery of training materials
• Utilize systems such as eQMS, CTMS, and eTMF platforms
• Ensure accurate tracking and documentation within applicable systems

Qualifications

• Bachelor's degree in a relevant scientific discipline preferred
• Minimum 2 years of clinical trial experience
• Experience in sponsor, CRO, or site environment preferred
• Exposure to QMS, audits, or SOP development is a plus
• Working knowledge of GCP and clinical trial processes
• Strong organizational and multitasking abilities
• High attention to detail and quality
• Sound judgment and problem-solving skills
• Proficiency in Microsoft Office (Excel, Word, PowerPoint)
• Familiarity with CTMS, eTMF, or eQMS systems preferred
• Ability and willingness for approximately up to 10% domestic travel and consistent with department needs