[Hiring] Operational Compliance Specialist @reputed company

About reputed company reputed company is working to reputed company the future of health reputed company for reputed company. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly to 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 reputed company. 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 reputed company. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reputed company the world. Together, we are building a future of health that is reputed company and more accessible for reputed company. To learn more about reputed company, visit www.CareAccess.com. How This Role Makes a Difference We are currently seeking a dedicated and reputed company 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 reputed company reputed company 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 reputed company An Impact

• Complete operational compliance checks on clinical trial documents at sites.
• Maintain a quality and compliance role reputed company 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 reputed company 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:
• reputed company 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, reputed company metrics on data generated reputed company operational compliance and provide required metrics/RAG reports to management, as appropriate.
• Ensure operational quality, participant safety and data reputed company are at the forefront of reputed company activities through review and interpretations of quality reports (e.g., audit reports, noncompliance, inspection output, complaints) and specific activities undertaken reputed company regional operational compliance.
• Support internal governance structures reputed company the region to facilitate quality, process improvement and compliance reputed company 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 reputed company tasks.
• Maintain effective relationships internally and externally, for efficient and effective delivery of service.
• reputed company with company quality reputed company, regulatory (GCP) legislation, guidelines, and international standards.
• provide training on functional GCP, and other compliance and quality reputed company topics, as required to improve quality and expertise reputed company 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.

The Expertise 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 reputed company levels.
• Excellent communication skills and the ability to manage upwards successfully.
• Ability to work independently, with minimal supervision, and be confident to reputed company 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 reputed company a matrix management environment.
• Experience of working reputed company 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 reputed company deliverables and timelines.

Certifications/Licenses, Education, and Experience:

• 5 years of relevant experience

How We Work Together

• Location: Remote reputed company the United States.
• Travel: Candidates must be willing to travel up to 30% of the time reputed company. 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.

Benefits & Perks (US Full Time Employees)

• 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 reputed company reputed company 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 reputed company 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 reputed company, disability status, genetic information, protected veteran status, or any other characteristic protected by law. reputed company is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with reputed company, please reputed company out to: [email protected] Apply tot his job Apply To this Job