Senior Specialist, Study Training Compliance – DoA Matrix Management

Job not on LinkedIn

🔥 6 minutes ago

🇺🇸 United States – Remote

💵 $60k - $80k / year

⏰ Full Time

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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CARE

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1945

🍽️ Food & Beverage

🏥 Healthcare

📦 Logistics

💰 Grant on 2021-11

Food & Beverage • Healthcare • Logistics

CARE is a boutique provider of high-quality, accredited carers for the Aged Care and Early Learning industries. It specializes in matching experienced professionals, recent graduates, and students with job vacancies in these sectors, facilitating rewarding career placements. CARE aims to support clients and carers by providing effective staffing solutions and contributing to their success in the industry.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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