Care Access is hiring an Operational Compliance Specialist

Care Access is hiring an Operational Compliance Specialist to establish and maintain a robust operational quality compliance framework for clinical trials within a designated region. You will drive process improvement, training, and compliance initiatives to enhance operational quality and long-term business success.

What You'll Do

• Complete operational compliance checks on clinical trial documents at research sites.
• Maintain a distinct quality and compliance role separate from routine operational quality control.
• Provide quality-focused support to achieve regulatory compliance and commercial objectives.
• Assist regional operational staff with robust Corrective Action and Preventive Action (CAPA) plan definition, ensuring compliance with SOPs and regulations.
• Maintain a regional CAPA owner listing and tracking mechanisms to ensure findings are addressed effectively.
• Escalate significant issues to management and the Quality Assurance (QA) function.
• Support regional staff with process improvement, procedure definition, and process mapping.
• Facilitate and report root cause analyses to aid CAPA definition and process improvement.
• Establish and maintain processes, procedures, and minimum expectations for operational compliance.
• Identify operational quality performance measures, collate compliance metrics, and provide required reports to management.
• Ensure operational quality, participant safety, and data integrity are prioritized through review of quality reports and specific activities.
• Support internal governance structures within the region to facilitate quality and compliance.
• Support the development and delivery of client governance and quality agreements in conjunction with QA and operational management.
• Support the QA function in preparing for client audits and regulatory inspections, investigating non-compliance, and tracking regional CAPA status.
• Maintain effective internal and external relationships for efficient service delivery.
• Comply with the company quality framework, GCP legislation, guidelines, and international standards.
• Provide training on GCP and other compliance topics to regional research center staff.
• Safeguard confidentiality of staff, participant, and sponsor information per data protection and GCP expectations.

What We're Looking For

• Expert working knowledge of GCP guidelines and quality regulations pertaining to clinical trials.
• In-depth knowledge of the requirements, best practices, and organization of a clinical research site.
• Minimum of 3 years experience as a clinical research auditor, CRA, or CTM, with exposure to internal audits and regulatory inspections.
• Experience training staff at all levels.
• Excellent communication skills and the ability to manage upwards successfully.
• Ability to work independently with minimal supervision, confident to make decisions and escalate appropriately.
• Willingness to travel regionally on a regular basis.
• Exceptional customer service skills for internal and external stakeholders.
• Experience working within a matrix management environment.
• Experience working within a highly regulated environment.
• Personal skills including assertiveness, persistence, flexibility, high organization, and detail orientation.
• Experience managing stressful situations and controversial issues while adhering to regulatory principles.
• Expertise in reviewing, revising, and writing Standard Operating Procedures.
• Ability to manage projects or teams of significant scope and complexity while meeting all deliverables and timelines.
• 5 years of relevant overall experience.

Team & Environment

You will be part of the regional team, supporting regional operational staff in a remote capacity within the United States.

Benefits & Compensation

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

Work Mode

This is a fully remote position open to candidates located within the United States.

Care Access is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.