Senior Specialist, Study Training Compliance – DoA Matrix Management

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

📋 Description

• Oversee and administer the completion of clinical staff training across various studies.

• Confirm the accuracy and relevance of training for assigned roles during the initiation and transition stages of studies.

• Ensure that training records are comprehensive, up-to-date, and adhere to ICH-GCP, SOPs, and sponsor documentation standards.

• Provide direction to internal teams and site personnel regarding training requirements and deadlines.

• Lead the establishment, review, and updates of the Delegation of Authority (DOA) matrix in line with protocol milestones.

• Validate training compliance and role appropriateness for delegated responsibilities, identifying any gaps prior to study activation.

• Act as a liaison for delegation matrix documentation during audits and monitoring visits.

• Upload, manage, and assess staff training records and certificates within the electronic Investigator Site File (eISF) and other internal systems.

• Maintain audit readiness for training and delegation matrix records across assigned studies.

• Prepare for and assist in internal audits, sponsor inspections, and document request responses.

• Collaborate with clinical teams and internal stakeholders throughout all phases of study execution.

• Contribute to the development of study-specific training plans and compliance tracking tools.

• Communicate with internal personnel, sponsors, and vendors to facilitate compliance activities and escalate any issues.

• Participate in meetings, providing expertise on training and DOA compliance operations.

• Identify opportunities for process improvements related to training workflows and delegation management.

• Assist in creating guidance materials, trackers, and internal SOPs.

• Perform additional duties as required.

⛳️ Requirements

• Strong comprehension of clinical research operations, training documentation, and the regulatory framework.

• Advanced organizational skills and meticulous attention to detail and documentation accuracy.

• Capability to handle multiple complex assignments with minimal supervision while adhering to deadlines in a fast-paced environment.

• Proficient in navigating and maintaining documentation across various platforms, including Florence (eISF), Clinical Conductor, and other training systems.

• Excellent communication and interpersonal abilities; capable of effectively coordinating with internal teams, site staff, vendors, and sponsors.

• Expertise in identifying and rectifying gaps in training documentation or delegation readiness.

• Proficient in Microsoft Office (Excel, Word, Outlook, SharePoint); experience with compliance tracking databases and tools.

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

• A minimum of 3–5 years of experience in a Central Support, Clinical Operations, or Clinical Research Compliance role, preferably within a regulated research setting.

• Proven track record in supporting or leading training compliance workflows, DOA matrix coordination, and documentation management across multiple clinical studies.

• Demonstrated ability to operate within quality-driven systems and maintain audit-ready documentation across various trials.

• Familiarity with eISF systems (Florence), CTMS tools, and sponsor portals is highly desirable.

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

• Care Access cannot sponsor work visas at this time.

🏝️ Benefits

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

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

• Health Savings Account and Flexible Spending Accounts.

• Bi-weekly HSA employer contributions.

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

• 401(k) Retirement Plan with Company Match.