Clinical Quality Assurance – GCP Specialist

Responsibilities

• Develop, implement, and maintain systems to ensure GCP compliance.
• Provide GCP support to clinical study teams to reduce compliance risks.
• Collaborate with Quality Assurance, Regulatory Affairs, and Clinical teams to develop GCP-compliant policies and SOPs.
• Support eTMF oversight, performing compliance checks and developing risk mitigation strategies.
• Support inspection readiness activities and trial-specific training.
• Site BIMO
• Sponsor BIMO
• Assess and document Clinical Operations process deviations.
• Collaborate with clinical trial teams to identify and improve operational processes.
• Interact with Clinical Development, Data Management, Finance, Regulatory, Quality Assurance, Safety & PV, Clinical Supply, and clinical vendors.
• Manage clinical CAPAs and conduct root cause investigations for deviations.
• Support compliance assessment, mitigation, and change control processes.
• Review essential documents (e.g., Clinical Protocols, Informed Consent Forms, Investigator’s Brochures, DSURs, Clinical Study Reports) for GCP adherence.
• Perform other duties as assigned.

Requirements

•  Bachelor’s degree in a scientific or related discipline, or 5 years of equivalent experience.
• 3-5 years of eTMF experience, including study start-up, maintenance, and quality reviews.
• 3+ years of experience in pharmaceutical industry roles related to clinical trials (e.g., clinical operations, project management).
• Experience in quality assurance or quality management activities. GCP Specialist • Experience with GCP vendor and site audits preferred.
• Ability to manage projects and tasks in a fast-paced environment.
• Analytical and critical thinking skills for quality review decision-making.
• Knowledge of pharmaceutical industry standards, including ICH/GCP guidelines.
• Experience with BIMO inspections preferred; EMA/MHRA/PDMA experience a plus.
• Communication skills, both verbal and written.
• • Leadership and problem-solving skills.
• Ability to translate strategy into operations and manage multiple priorities.
• Ability to work independently with limited supervision.

Work Environment / Physical Demands

• Primarily office-based with required time in clinical trial settings addressing compliance and documentation.
• Requires prolonged periods of computer use for data analysis, documentation, and report generation related to compliance processes.
• May involve lifting office materials up to 20 pounds.
• Ability to navigate office and clinical environments for audits and training activities