Specialist, Study Training Compliance – DOA Management

📋 Description

• Monitor and track the completion of training for clinical staff, encompassing both study-specific and mandatory compliance training.

• Assist with delegation processes during the initiation of studies by ensuring that training is appropriate for assigned roles.

• Verify that training documentation is comprehensive, up-to-date, and adheres to ICH-GCP, SOP, and sponsor standards.

• Aid in the establishment and upkeep of the DOA matrix by confirming training completion and role assignments.

• Collaborate across departments to ensure readiness for protocol activities and transitions between studies.

• Upload and manage critical staff training records, certifications, and related documents in the eISF and associated systems.

• Ensure that site staff training records are prepared for audits and comply with regulatory and sponsor requirements.

• Partner with internal stakeholders to facilitate study training and access coordination throughout various study phases.

• Effectively communicate with internal staff, sponsors, and vendors regarding compliance-related tasks and timelines.

⛳️ Requirements

• Preferred Bachelor’s degree in Life Sciences, Health Administration, or a related field.

• At least 2 years of experience in a Central Support or clinical research support role at Care Access or a similar organization (in clinical research, training compliance, operations, or document management in a regulated environment).

• Demonstrable experience in supporting onboarding, training compliance, and/or access coordination within a regulated research setting.

• Proven ability to navigate and operate within compliance-focused systems and manage multi-trial documentation workflows.

• Knowledge of eISF (Florence) and clinical training platforms is advantageous.

🏝️ 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