Specialist, Study Training Compliance – DoA Matrix Management

This is a fully remote position, open to applicants in United States.

📋 Description

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

• Assist in the delegation processes during study initiation by ensuring that training is aligned with assigned responsibilities.

• Verify that training documentation is comprehensive, up-to-date, and compliant with ICH-GCP, SOP, and sponsor requirements.

• Aid in the setup and maintenance of the DOA matrix by confirming training completion and role assignments.

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

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

• Maintain audit-ready staff training records that align with regulatory standards and sponsor expectations.

• Support internal audits, monitoring visits, and requests for documentation from sponsors.

• Work with internal stakeholders to facilitate study training and coordinate access throughout various study phases.

• Engage in team meetings and contribute to documentation and communication tools that enhance team productivity.

• Raise issues or delays to senior team members to ensure compliance timelines for studies and sites are met.

• Communicate with internal personnel, sponsors, and vendors regarding compliance tasks and schedules.

• Assist in resolving training or access challenges with the wider team.

• Carry out other assigned duties as necessary.

⛳️ Requirements

• Knowledge of clinical research operations and the significance of compliance and documentation.

• Excellent organizational and tracking abilities; detail-oriented with the capacity to handle multiple tasks efficiently.

• Comfortable utilizing technology platforms (e.g., Clinical Conductor, Florence, SIP).

• Proficiency in Microsoft Office is required.

• Strong communication and interpersonal skills for effective cross-functional collaboration.

• Ability to work independently and as part of a cooperative team.

• Professional and adaptable in interactions with providers, vendors, and sponsor representatives.

• Familiarity with Microsoft Office applications, especially Excel, Word, Outlook, and SharePoint.

• Experience with internet-based research and database systems.

• Strong interpersonal and customer service skills.

• A Bachelor's degree in Life Sciences, Health Administration, or a related field is preferred.

• At least 2 years of experience in a Central Support or clinical research support position at Care Access or a similar organization.

• Proven track record in supporting onboarding, training compliance, and/or access coordination in a regulated research setting.

• Demonstrated capability to navigate and operate within compliance-driven systems and assist with multi-trial documentation workflows.

• Familiarity with eISF (Florence) and clinical training platforms is advantageous.

• Must be able to work remotely within the United States.

• Care Access is currently unable to sponsor work visas.

🏝️ Benefits

• Paid Time Off (PTO) and Company Paid Holidays.

• 100% Employer-covered medical, dental, and vision insurance plan options.

• Health Savings Account and Flexible Spending Accounts.

• Bi-weekly contributions to HSA from the employer.

• Company-paid Short-Term and Long-Term Disability.

• 401(k) Retirement Plan with Company Match.