Operational Compliance Specialist

Role Overview

• 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.
• As part of the regional team, provide quality focused support to the business so that regulatory compliance and commercial objectives are achieved.
• Assist regional operational staff with 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 regional CAPA owner listing and robust mechanisms for ensuring quality findings and CAPAs are addressed, implemented and effective.
• Escalate issues to management/QA.
• Support regional 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
• Regional 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 regional operational compliance.
• Support internal governance structures within the region 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 regional 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 regional research centres.
• Safeguard confidentiality of staff, participant and sponsor matters as required by regional Data Protection and Good Clinical Practice expectations.

Requirements

• Expert working knowledge of GCP guidelines and quality regulations/expectations pertaining to clinical trials.
• In depth knowledge and understanding of the requirements, best practice, and organisation of a clinical research site.
• Worked as a clinical research auditor or clinical research associate (CRA) / clinical trials monitor (CTM) for at a minimum of 3 years and have had exposure to internal audits as well as Regulatory Body inspections.
• Experience in training other members of staff at all levels.
• Excellent communication skills and the ability to manage upwards successfully.
• Ability to work independently, with minimal supervision, and be confident to make local decisions and escalate accordingly.
• Willingness to travel regionally on a regular basis.
• Exceptional customer services skills to both internal and external stakeholders.
• An understanding and experience of working within a matrix management environment.
• Experience of working within a highly regulated environment.
• Personal skills including assertiveness, persistence, flexibility, highly organized and detail oriented.
• Experience in managing stressful situations and managing controversial issues whilst firmly adhering to the principles of the regulations and guidelines.
• Expertise in reviewing, revising, and writing Standard Operating Procedures.
• Ability to manage projects / teams of significant scope and complexity, while meeting all deliverables and timelines.

Tech Stack

• Google Cloud Platform

Benefits

• Paid Time Off (PTO) and Company Paid Holidays
• 100% Employer paid medical, dental, and vision insurance plan options
• Health Savings Account and Flexible Spending Accounts
• Bi-weekly HSA employer contribution
• Company paid Short-Term Disability and Long-Term Disability
• 401(k) Retirement Plan, with Company Match