CARE

We work to fight poverty and achieve social justice by empowering women and girls. www.CARE.org

Specialist, Study Training Compliance – DOA Management

ComplianceComplianceFull TimeRemoteTeam 5,001-10,000Since 1945H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

60 days ago

Salary

Not specified

Bachelor Degree2 yrs expEnglishGoogle Cloud Platform

Job 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 documentation of training 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 that site staff training records are audit-ready and aligned with regulatory and sponsor expectations. • 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 as appropriate to ensure study and site compliance timelines are met. • Communicate effectively with internal staff, sponsors, and vendors regarding compliance tasks and timelines. • Assist in problem-solving training, or access issues, contributing to solutions in collaboration with the broader team.

Job Requirements

  • 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 (in clinical research, training compliance, operations, or document management in a regulated environment).
  • 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.

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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