Senior Specialist, Study Training Compliance – DoA Matrix Management

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🕒 Ontem

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $60.000 - $80.000 / ano

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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CARE

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

Fundada em 1945

🍽️ Alimentos e Bebidas

🏥 Saúde

📦 Logística

💰 Grant em 2021-11

Food & Beverage • Healthcare • Logistics

A CARE é uma organização humanitária global dedicada a acabar com a pobreza e oferecer ajuda vital. Há quase 80 anos, a organização fornece resposta a emergências, alimentos e água, serviços de saúde, educação e programas voltados para mulheres e meninas em mais de 120 países, enfatizando soluções lideradas localmente e alta eficiência dos programas. A CARE opera como uma organização sem fins lucrativos 501(c)(3) que arrecada doações e mobiliza esforços de advocacia e desenvolvimento para aliviar a fome, promover a igualdade e apoiar a resiliência comunitária a longo prazo.

Descrição

• Monitor and manage clinical staff training completion across multiple studies • Verify training accuracy and appropriateness for assigned roles during study start-up and transition phases • Ensure training records are 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 • Lead Delegation of Authority (DOA) matrix setup, review, and updates in alignment with protocol milestones • Confirm training compliance and role alignment for delegated tasks and flag gaps before study activation • Serve as a point of contact for delegation matrix documentation during audits and monitoring visits • Upload, maintain, and review staff training records and certificates within the electronic Investigator Site File (eISF) and other internal systems • Ensure audit-readiness of training and delegation matrix documentation across assigned studies • Prepare for and support internal audits, sponsor inspections, and document request responses • Collaborate with clinical teams and internal stakeholders across all phases of study execution • Contribute to study-specific training plans and compliance tracking tools • Communicate with internal staff, sponsors, and vendors to support compliance activities and escalate issues • Participate in meetings and provide subject matter input on training and DOA compliance operations • Identify process improvement opportunities related to training workflows and delegation management • Assist with guidance materials, trackers, and internal SOPs • Perform other duties as assigned

🎯 Requisitos

• 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 • Bachelor's degree in Life Sciences, Health Administration, Clinical Research, or a related field preferred • 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 across multiple trials • Familiarity with eISF systems (Florence), CTMS tools, and sponsor portals is strongly preferred • Must be able to work remotely within the United States • Care Access is unable to sponsor work visas at this time

🏖️ Benefícios

• 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