Specialist, Study Training Compliance – DoA Matrix Management

Job not on LinkedIn

🔥 16 hours ago

🇺🇸 United States – Remote

💵 $50k - $70k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🚔 Compliance

🚫👨‍🎓 No degree required

🦅 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

• 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

🎯 Requirements

• 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

🏖️ 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

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