Remote Operational Compliance Specialist

Summary

Join our team as an Operational Compliance Specialist and play a crucial role in leading and executing an operational quality compliance framework, driving process improvement initiatives, training, and compliance across the region.

Responsibilities

• Complete operational compliance checks on clinical trial documents at sites
• Maintain a quality and compliance role within operations, separate from operational quality control (QC) and routine operational activities
• Provide quality focused support to the business so that regulatory compliance and commercial objectives are achieved
• Assist clinical operational staff with Quality Issue Management, Corrective Action and Preventive Action Plan (CAPA) definition to ensure adequacy, robustness, and compliance with Standard Operating Procedures (SOPs), regulations and best practice
• Maintain a CAPA owner listing and robust mechanisms for ensuring quality findings and CAPAs are addressed, implemented and effective
• Escalate issues to management/QA
• Support staff with process improvement and procedure definition and process mapping, where applicable
• Facilitate and report root cause analysis to aid CAPA definition and process improvement, where applicable
• Establish and maintain processes, procedures, and minimum expectations for operational compliance (OC), including, but not limited to
• Oversight of quality control (QC), CAPA and process effectiveness
• Process for OC assessments, including scope/purpose/responsibilities
• A risk-based approach
• Local OC activity schedule
• Process for OC output reporting, trending, distribution, follow up and CAPA definition
• Identify operational quality performance measures, collate metrics on data generated within operational compliance and provide required metrics/RAG reports to management, as appropriate
• Ensure operational quality, participant safety and data integrity are at the forefront of all activities through review and interpretations of quality reports (e.g., audit reports, noncompliance, inspection output, complaints) and specific activities undertaken via operational compliance
• Support internal governance structures to facilitate quality, process improvement and compliance within operations
• Support development and delivery of client governance/quality agreements in conjunction with QA and operational management
• Support the QA function with regards to notification, preparation and facilitation of client audit and regulatory inspections, investigations of non-compliance and tracking and follow up of CAPA status ensuring on time completion of quality related tasks
• Maintain effective relationships internally and externally, for efficient and effective delivery of service
• Comply with company quality framework, regulatory (GCP) legislation, guidelines, and international standards
• Provide training on functional GCP, and other compliance and quality related topics, as required to improve quality and expertise within the operation of the research centres
• Safeguard confidentiality of staff, participant and sponsor matters as required by regional Data Protection and Good Clinical Practice expectations