Operational Compliance Specialist
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Job Description
Operational Compliance Specialist at Care Access leading operational compliance checks for clinical trials. Ensuring quality, efficiency, and regulatory adherence across the regional teams.
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.
- 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 oversight of quality control (QC), CAPA and process effectiveness.
- Process for OC assessments, including scope/purpose/responsibilities with a risk-based approach.
- Identify operational quality performance measures, collate metrics, 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 and specific activities undertaken via regional operational compliance.
- Support internal governance structures within the region to facilitate quality, process improvement and compliance within operations.
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 organization of a clinical research site.
- Worked as a clinical research auditor or clinical research associate (CRA) / clinical trials monitor (CTM) for 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.
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
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