The Operational Compliance Specialist ensures compliance in clinical trials, manages CAPA processes, and improves operational quality and efficiency across the region.
About Care Access
Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow.
With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all.
To learn more about Care Access, visit www.CareAccess.com.
We are currently seeking a dedicated and experienced professional for the position of Operational Compliance Specialist. As an Operational Compliance Specialist, you will play a crucial role in leading and executing an operational quality compliance framework within a designated region. Your main objective will be to drive and deliver operational quality and process improvement initiatives, training, and compliance across the region, ultimately increasing operational quality, efficiency, and long-term business success.
How You'll Make An Impact
The Expertise RequiredHow We Work Together
- 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.
- 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.
Certifications/Licenses, Education, and Experience:
- 5 years of relevant experience
- Location: Remote within the United States.
- Travel: Candidates must be willing to travel up to 30% of the time nationwide. Frequency and length of travel may depend on need for on-site visits.
- Physical demands associated with this position Include: The ability to use keyboards and other computer equipment.
- 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
Diversity & Inclusion
We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, 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.
Care Access is unable to sponsor work visas at this time.
If you need an accommodation to apply for a role with Care Access, please reach out to: [email protected]
Top Skills
Clinical Trial Regulations
Gcp Guidelines
Standard Operating Procedures
Care Access Boston, Massachusetts, USA Office
33 Arch Street, 17th Floor, Boston, MA, United States, 02110
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