Care Access · 18 hours ago
Operational Compliance Specialist
United States
Full-time
Remote
Senior Level
5+ years expCare Access is working to make the future of health better for all. As an Operational Compliance Specialist, you will lead and execute an operational quality compliance framework, focusing on improving operational quality and compliance within clinical trials across the region.
Clinical TrialsHealth Care
No H1B
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, 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
Qualification
Required
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 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
Research 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
5 years of relevant experience
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
Company
Care Access
Care Access helps people learn more about their health and participate in clinical research to help find new medicines and cures.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Biomedical Advanced Research and Development Authority (BARDA)
2024-08-26Grant
Leadership Team
Ahmad Namvargolian
CEO, Co-Founder
Recent News
2026-01-23
Company data provided by crunchbase