GCP Specialist
- 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 SIMO
- 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
- 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
- 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
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