Remote Senior Specialist, Study Training Compliance & DOA

Openkrill

United States

Remote

USD 60,000 - 80,000

Full time

5 days ago
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Benefits offered by this job

PTO
Health insurance
HSA/FSAs
401(k) match
Disability insurance

Job summary

Care Access is seeking a Senior Specialist, Study Training Compliance and DOA Matrix Management, to join our Global Expansion and Study Operations team. You will coordinate training compliance, DOA matrix setup, and documentation across multiple clinical studies while ensuring regulatory alignment and audit readiness.

The ideal candidate has 3–5 years in central support or clinical research compliance, strong understanding of eISF systems (Florence) and CTMS tools, and excellent communication

Qualifications

  • Experience in central support, clinical operations, or clinical research compliance in a regulated environment.
  • Ability to manage multiple complex assignments with minimal oversight and deadlines.
  • Knowledge of training workflows and delegation processes.
  • Familiarity with eISF systems (Florence) and sponsor portals is preferred.

Responsibilities

  • Oversee training compliance across studies and ensure alignment with ICH-GCP and SOPs.
  • Coordinate DOA matrix setup, reviews, and updates and verify role/task alignment.
  • Maintain training records in eISF and internal systems and support audits/inspections.
  • Collaborate with clinical teams and sponsors to ensure training readiness across study phases.
  • Assist with guidance materials, trackers, and internal SOPs and drive process improvements.

Skills

Clinical operations
Training documentation
Regulatory environment
Documentation accuracy
Cross-functional communication
MS Office

Education

Bachelor’s degree in Life Sciences/Health Admin/Clinical Research

Tools

Florence eISF
CTMS
Sponsor portals
MS Office

Job description

Care Access is seeking a Senior Specialist, Study Training Compliance and DOA Matrix Management, to join our Global Expansion and Study Operations team. You will coordinate training compliance, DOA matrix setup, and documentation across multiple clinical studies while ensuring regulatory alignment and audit readiness.

The ideal candidate has 3–5 years in central support or clinical research compliance, strong understanding of eISF systems (Florence) and CTMS tools, and excellent communication

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