Senior Specialist, Study Training Compliance, DOA Management

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November 20

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CARE

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Healthcare Insurance • Education • Recruitment

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.

5001 - 10000 employees

Founded 1945

⚕️ Healthcare Insurance

📚 Education

🎯 Recruiter

💰 Grant on 2021-11

📋 Description

• 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. • 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. • 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. • 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.

🎯 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.

🏖️ 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