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This position works independently while serving as a key regulatory and compliance resource for key ABH stakeholders, investigators, research staff, sponsors, clinical research organizations (CRO) and external entities. This role ensures that all research activities are conducted in accordance with applicable regulations, institutional policies, Standard Operating Procedures (SOPs), and study-specific protocols and plans. They will drive study-specific and site-specific will be responsible for essential document creation and gathering, IRB submissions, investigator site file (ISF) management, sponsor interactions and general regulatory oversight. Studies may include large, multisite national trials or moderately complex protocols involving multiple assessments and/or interventions. This is a high autonomy, site-specific leadership role for an experienced regulatory professional who understands how to operate within a busy clinical research environment and can independently manage regulatory requirements from study start-up through close-out. The Senior Regulatory Specialist will serve as the primary regulatory subject matter expert for the site, partnering closely with Principal Investigators, the Site Director, Clinical Research Coordinators, Research Nurses, sponsors, CROs, IRBs, GAP Leadership and other stakeholders. This individual will be responsible not only for completing regulatory activities, but for building and maintaining a proactive, inspection-ready regulatory infrastructure across the site. The ideal candidate is a strategic regulatory professional who can identify risks before they become findings, confidently communicate with sponsors and investigators, manage competing priorities across multiple protocols, and establish processes that support high-quality clinical trial execution. Key Responsibilities Site Regulatory Leadership & Oversight Serve as the primary regulatory point of contact and subject-matter expert for the research site. Own regulatory activities across assigned studies from start-up through close-out. Develop and maintain study-specific regulatory plans, timelines, and tracking systems. Ensure regulatory activities are completed accurately, consistently, and within required timelines. Proactively identify regulatory and compliance risks and develop appropriate mitigation strategies. Maintain comprehensive knowledge of each assigned protocol, investigator responsibilities, regulatory requirements, and study-specific obligations. Partner with site leadership to ensure regulatory requirements are incorporated into day-to-day trial operations. Partner with GAP Owned & Operated Site (GOOS) leadership to ensure regulatory requirements and reporting requirements are met. Regulatory Submissions & Essential Documents Independently prepare, review, submit, and maintain regulatory documentation, including: Initial IRB submissions Continuing reviews Amendments and modifications Protocol deviations Safety reports and reportable events Investigator changes Study-specific regulatory documents Prepare and maintain FDA Form 1572s, investigator agreements, financial disclosures, signature pages, CVs, medical licenses, training records, and other essential documents. Support IND/IDE-related activities and FDA submissions, as applicable. Maintain applicable ClinicalTrials.gov information, as applicable. Ensure electronic Investigator Site Files (eISFs) and institutional regulatory files remain complete, accurate, current, and inspection ready. Inspection, Audit & Compliance Readiness Own site regulatory readiness for sponsor audits, monitoring visits, internal audits, and regulatory inspections. Conduct proactive reviews of regulatory files to identify gaps and implement corrective actions. Partner with site and

GAP GOOS

leadership to address compliance concerns, potential breaches, reportable events, and audit findings. Support CAPA activities and implementation of sustainable process improvements. Maintain awareness of evolving FDA, ICH-GCP, IRB, HIPAA, privacy, and applicable international requirements. Sponsor, CRO & Investigator Partnership Serve as a senior regulatory resource to Principal Investigators, Sub-Investigators, research staff, sponsors, and CROs. Independently respond to regulatory inquiries and resolve documentation or compliance issues. Coordinate regulatory activities and timelines between the site, sponsors, CROs, IRBs, and investigators. Participate in study start-up meetings, investigator meetings, monitoring visits, and close-out activities as needed. Establish credibility and strong working relationships with external partners. Team Leadership & Development Provide regulatory guidance, training, and mentorship to clinical research staff. Serve as a resource for coordinators and other team members regarding regulatory requirements and best practices. Help establish and improve site regulatory processes, tools, SOPs, and workflows. Promote a culture of inspection readiness, accountability, quality, and continuous improvement. What We're Looking For Required Bachelor's degree in health science, life science, public health, or related field, or equivalent combination of education and experience. 2+ years of clinical research regulatory experience, preferably within a research site environment. Demonstrated ability to independently manage regulatory activities for multiple clinical trials.

Strong working knowledge of:

FDA regulations

ICH-GCP IRB

requirements and processes HIPAA and clinical research privacy requirements Demonstrated experience maintaining inspection ready ISFs and essential regulatory documentation. Experience interacting directly with sponsors, CROs, investigators, and IRBs. Strong understanding of study start-up, ongoing study conduct, and close-out regulatory requirements. Excellent organizational, communication, problem-solving, and prioritization skills. Ability to work independently, exercise sound judgment, and take ownership of site-level responsibilities. Preferred Experience supporting FDA inspections, sponsor audits, or CRO audits. Experience developing or improving regulatory processes, SOPs, or compliance systems. Experience providing regulatory leadership, mentorship, or oversight to other research staff. ACRP, SOCRA, RAPS, or comparable regulatory/clinical research certification. Experience in Alzheimer's disease, Parkinson's disease, dementia, MS, or other neuroscience/CNS clinical research. Experience with complex, multi-site, interventional clinical trials. Experience with IND/IDE-related activities. Experience with ClinicalTrials.gov. Experience with RealTime CTMS/eSource/eDOC or similar electronic systems Why This Role This is an opportunity to join a mission-driven clinical research organization at an exciting stage of growth and have a direct impact on how regulatory operations are executed at the site. You will have the autonomy and visibility to build, improve, and lead regulatory processes, work directly with investigators and industry sponsors, and help ensure the site remains compliant, inspection ready, and positioned to successfully execute innovative clinical trials in neuroscience and neurodegenerative disease. The duties above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Compensation Salary Range:

$70,000-95,000 Benefits may include health insurance, retirement savings, paid time off, performance incentives, and professional development opportunities.

Pay:

$70,000.00 - $95,000.00 per year

Benefits:

401(k) Dental insurance Employee assistance program Health insurance Paid time off Parental leave Retirement plan Tuition reimbursement Vision insurance

Work Location:

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Senior Clinical Research Regulatory Specialist, Axiom Brain Health