Senior Specialist, Study Training Compliance & DoA Matrix Management
Care Access · Remote — United States
عن بُعد60 ألف US$ – 80 ألف US$ سنوياً
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تسجيل الدخولملخص الوظيفة
- المكان
- Remote — United States
- نمط العمل
- عن بُعد
- نوع العمل
- دوام كامل
- مستوى الخبرة
- خبير
- الراتب
- 60 ألف US$ – 80 ألف US$ سنوياً
- تاريخ النشر
- 11 أكتوبر 2026
- آخر تحقق من المصدر
- 11 أكتوبر 2026
- مصدر الوظيفة
- عبر Himalayas
المزايا
• 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
المهارات
- Excel
- Google Cloud
- Microsoft Office
- Auditing
- Operations
- Communication
التأشيرة والانتقال
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الإعلان لا يذكر دعم الانتقال.
وصف الوظيفة
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 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 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 .
How This Role Makes a Difference
Care Access is seeking a skilled and experienced Senior Specialist, Study Training Compliance and DOA Matrix Management, to join our dynamic Central Support Operations team, part of the Global Expansion and Study Operations department.
This role plays a critical function in overseeing the coordination and execution of training compliance and delegation documentation across a portfolio of clinical research studies. The Senior Specialist ensures alignment with regulatory standards and sponsor expectations by tracking training completion, maintaining site staff study-training records, and driving the timely review and approval of Delegation of Authority (DOA) matrices.
As a senior-level contributor, supports cross-functional partners, resolves complex documentation and compliance challenges, and contributes to process improvements that enhance operational efficiency. The ideal candidate brings a strong foundation in clinical research operations, deep familiarity with training workflows and delegation processes, and a commitment to documentation integrity in a fast-paced, regulated environment.
How You'll Make An Impact
• Study Training Compliance
• Monitor and manage clinical staff training completion across multiple studies, ensuring alignment with study-specific and mandatory compliance requirements.
• Verify training accuracy and appropriateness for assigned roles during study start-up and transition phases.
• Ensure training records are consistently complete, current, and compliant with ICH-GCP, SOPs, and sponsor documentation standards.
• Provide guidance to internal teams and site staff on training requirements and timelines.
• Delegation of Authority (DOA) Matrix Coordination
• Lead coordination of DOA matrix setup, review, and updates in alignment with protocol milestones.
• Confirm training compliance and role alignment for delegated tasks; flag gaps for resolution before study activation.
• Serve as a point of contact for delegation matrix-related documentation during audits and monitoring visits.
• eISF & Documentation Oversight
• Upload, maintain, and review essential staff training records and certificates within the electronic Investigator Site File (eISF) and other internal systems.
• Ensure audit-readiness of all training and delegation matrix documentation across assigned studies.
• Prepare for and support internal audits, sponsor inspections, and document request responses related to study training compliance.
• Cross-Functional Support & Collaboration
• Collaborate with clinical teams and other internal stakeholders to ensure training and delegation readiness across all phases of study execution.
• Contribute to study-specific training plans and compliance tracking tools to improve visibility and standardization.
• Communicate proactively with internal staff, sponsors, and vendors to support compliance activities and escalate issues when necessary.
• Participate in meetings and provide subject matter input on training and DOA compliance operations.
• Identify and contribute to process improvement opportunities related to training workflows and delegation management.
• Assist with the creation and refinement of guidance materials, trackers, and internal SOPs.
• Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.
The Expertise Required
• Strong understanding of clinical research operations, training documentation, and the regulatory environment.
• Advanced organizational and tracking skills with attention to detail and documentation accuracy.
• Ability to manage multiple complex assignments with minimal oversight while meeting deadlines in a fast-paced setting.
• Comfortable navigating and maintaining documentation across platforms such as Florence (eISF), Clinical Conductor, and other training systems.
• Excellent communication and interpersonal skills; able to coordinate effectively with internal teams, site staff, vendors, and sponsors.
• Skilled in identifying and addressing gaps in training documentation or delegation readiness.
• Proficient in Microsoft Office (Excel, Word, Outlook, SharePoint); experience with compliance tracking databases and tools.
Certifications/Licenses, Education, and Experience
• Minimum Education:
• Bachelor’s degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred.
• Minimum Experience:
• Minimum of 3–5 years of experience in a Central Support, Clinical Operations, or Clinical Research Compliance role, ideally within a regulated research environment.
• Proven success supporting or leading training compliance workflows, DOA matrix coordination, and documentation management across multiple clinical studies.
• Demonstrated ability to work within quality-driven systems and maintain audit-ready documentation acro
التقديم من الموقع الأصلي ↗مصدر الوظيفة: عبر Himalayas
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