JOB SUMMARY

The Compliance Specialist will be responsible for providing oversight, mentoring and guidance to staff and ensuring compliance with all appropriate guidelines for legal, regulatory, and site compliance, as well as company policies and procedures.
They will also provide support to the site regarding Quality Management System (QMS), follow-up on CAPAs, preparation for internal and external audits, operational compliance checks, identification and/or support in reporting of QI and communication of any issues with site.

• Building key relationships with stakeholders, colleagues, clients, monitors and CRA’s
• Responsible for complex data collection, transcribing information into case report forms in accordance with Good Clinical Practice
• Ensuring accuracy and high quality of data input in to Panthera systems
• Ensuring patient notes are always complete and up to date
• Responsibility for safeguarding and ensuring the quality of information for patients, clients and vendors
• Prepares individual/site operational compliance plans and performs quarterly operational compliance check activities.
• Prepares associated reports and follows up on quality issues from all sources and related CAPAs.
• Performs regular quality control and oversees that quality of data is accurate, on time and adheres to latest approved SOPs, COP’s standards, GCPs, Local Regulatory and protocol.
• Validates and checks quality of essential documents, participant files and site study data, ensuring accuracy of data entered and source documents and reports discrepancies.
• Develops, maintains and produces a dashboard for tracking patients, flow of CRFs, and queries, ensuring that this is provided in a timely manner.
• Conducts, hosts, and produces meeting minutes and actions for departmental and other relevant meetings, ensuring that issues impacting on business are highlighted to senior leaders as needed.
• Monitor’s quality and training processes to ensure appropriate timelines are met
• Completes the preparation for monitoring visit duties and audits and clarifies concerns related to CRF completions; resolves queries as well as CAPA reporting and basic root cause analyses.
• Identifies trends in data queries and escalates appropriately.
• Supports QA regarding notifications, preparations and facilitation of client audit and regulatory inspections, investigations of quality issues and tracking and follow up of local CAPA status.
• Ensures that quality and patient safety are at the forefront of all activities through review and interpretations of audit reports, quality statistics and operating procedure robustness, and follows up on quality issues.
• Ensures robust application and compliance with Good Clinical Practice and Data Protection Act or SOPs, QA and applicable regulatory guidelines