Specialist, Study Training Compliance – DoA Matrix Management

Vaga não está no LinkedIn

🕒 Novembro 3

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $50.000 - $70.000 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🚔 Conformidade

🚫👨‍🎓 Sem graduação necessária

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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

• Track and monitor clinical staff training completion, including study-specific and mandatory compliance training • Support delegation processes during study start-up by verifying that training aligns with assigned roles • Ensure training documentation is complete, current, and meets ICH-GCP, SOP, and sponsor requirements • Support DOA matrix setup and maintenance by confirming training completion and role assignments • Work cross-functionally to ensure delegation readiness for protocol activities and study transitions • Upload and maintain essential staff training records, certifications, and staff documents in the eISF and associated systems • Ensure site staff training records are audit-ready and aligned with regulatory and sponsor expectations • Support internal audits, monitoring visits, and sponsor document requests • Collaborate with internal stakeholders to support study training and access coordination across study phases • Participate in team meetings and contribute to documentation and communication tools to enhance team efficiency • Escalate issues or delays to senior team members to ensure study and site compliance timelines are met • Communicate with internal staff, sponsors, and vendors regarding compliance tasks and timelines • Assist in resolving training or access issues with the broader team • Perform other duties as assigned

🎯 Requisitos

• Understanding of clinical research operations and the importance of compliance and documentation • Strong organizational and tracking skills; detail-oriented with the ability to manage multiple tasks effectively • Comfortable working with technology platforms (e.g., Clinical Conductor, Florence, SIP) • Microsoft Office proficiency required • Strong interpersonal and communication skills for cross-functional teamwork • Ability to work both independently and as part of a collaborative team • Professional and adaptable when interacting with providers, vendors, and sponsor representatives • Knowledge of Microsoft Office applications, particularly Excel, Word, Outlook, and SharePoint • Familiarity with internet-based research and database systems • Strong interpersonal and customer service skills • Bachelor's degree in Life Sciences, Health Administration, or a related field preferred • Minimum of 2 years of experience in a Central Support or clinical research support role at Care Access or within a comparable organization • Proven experience supporting onboarding, training compliance, and/or access coordination in a regulated research environment • Demonstrated ability to navigate and work within compliance-driven systems and support multi-trial documentation workflows • Familiarity with eISF (Florence) and clinical training platforms is a plus • 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

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