Specialist, Study Training Compliance – DOA Management
CARE
full-time
Posted on:
Location Type: Remote
Location: United States
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Tech Stack
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
training compliancedocument managementonboardingmulti-trial documentation workflows
Soft skills
communicationproblem-solvingcollaborationcross-functional teamworkorganizational skills