Role Summary
As a GCP Specialist, you will support GCP compliance for clinical operations to ensure regulatory adherence. You will assist in compliance processes and collaborate with cross functional teams to maintain clinical trial integrity. 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 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 Qualifications
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 Additional Requirements
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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As a GCP Specialist, you will support GCP compliance for clinical operations to ensure regulatory adherence. You will assist in compliance processes and collaborate with cross functional teams to maintain clinical trial integrity. 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 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 Qualifications
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 Additional Requirements
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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