Sr. Regulatory Specialist, Clinical Research

This is a CONTRACT, onsite (Tampa) position--3 months with option to renew

The Sr. Clinical Research Regulatory Specialist at Axiom Brain Health, LLC (ABH) leads, coordinates, and oversees regulatory work at the site. 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 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, multi-site national trials or moderately complex protocols involving multiple assessments and/or interventions.

Key Responsibilities

Regulatory Oversight

● Understand and comply with all applicable laws, regulations, policies, and procedures governing clinical research

● Monitor and stay current with local, state, federal, international (GDPR) and sponsor-specific regulatory changes that may impact research operations

● Maintain a comprehensive understanding of each clinical trial conducted at the site, including protocols, inclusion/exclusion criteria, and study-specific regulatory requirements

● Submit regulatory documents to support:

○ Initial study reviews

○ Continuing reviews

○ Amendments and modifications

○ Protocol deviations

○ Safety reports and reportable events

● Prepare and maintain essential regulatory documents for study sponsors, including but not limited to:

○ FDA Form 1572 / Investigator Agreements

○ Financial Disclosure Forms (FDF)

○ Signature and Acknowledgement Pages

○ Investigator and staff CVs, medical licenses, and training documentation

● Prepare and support submissions to the FDA for IND/IDE-related activities, as applicable

● Submit and maintain Clincialtrials.gov, as appliable

● Establish and maintain tracking systems for all submitted and approved IRB applications, regulatory forms, general and study specific training, and essential documents

● Maintain inspection-ready Investigator Site Files (ISF) and institution processing and practices

● Partner with institutional GAP Leaders to address potential breaches, reportable events, or compliance concerns

● Support internal and external audits, sponsor monitoring visits, and regulatory inspections

● Provide regulatory guidance during study start-up, conduct, and close-out

● Provide regulatory training to site-staff

● Other responsibilities as assigned

Collaboration & Support

● Act as a regulatory resource for ABH stakeholders, research staff and physicians

● Coordinate regulatory-related activities between ABH stakeholders, study sponsors, investigators, and clinical research staff

● Respond to regulatory inquiries from sponsors, monitors, and oversight bodies

Qualifications

Required

● Bachelor’s degree in health science, life science, public health, or related field (or equivalent experience)

● Minimum of 3–5 years of clinical research regulatory experience

● Strong knowledge of:

○ US FDA regulations

○ ICH-GCP guidelines

○ IRB processes and requirements

● Working knowledge of HIPAA and clinical research privacy requirements

● Experience preparing and maintaining Investigator Site Files (ISF), essential documents and institution level documents

● Excellent organizational skills with strong attention to detail

● Excellent written and verbal communication skills

Preferred

● Experience in sponsored clinical trials

● Experience supporting FDA inspections or sponsor and vendor audits

● RAPS, SOCRA or ACRP certification (e.g., CCRP, CCRC)

● Experience in Alzheimer’s disease or neuroscience research

Key Competencies

● Ability to work independently and manage multiple studies simultaneously

● Strong problem-solving and critical thinking skills

● Ability to interpret complex regulations and apply them to research operations

● High level of integrity and commitment to participant privacy and data protection

● Collaborative mindset with the ability to build relationships across a large organization

The duties above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

Pay: $65,000.00 - $85,000.00 per year

Work Location: In person