Sr Regulatory Specialist, Clinical Research - 119425

Medix™

Tampa, FLContractorPosted May 6, 2026

Behavioral Health Market Context

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Qualifications

  • •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
  • •○ 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
  • •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
  • •11 more items(s)

Responsibilities

  • •Clinical Research Regulatory Specialist 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
  • •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:
  • •○ Safety reports and reportable events
  • •Prepare and maintain essential regulatory documents for study sponsors, including but not limited to:
  • •○ FDA Form 1572 / Investigator Agreements
  • •○ 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 applicable
  • •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 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
  • •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
  • •23 more items(s)
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