Regional Regulatory Specialist

Flourish Research is seeking a Regional Regulatory Specialist to manage and coordinate regulatory documents and activities for clinical research studies. The role involves working with site leadership, principal investigators, and regulatory bodies to ensure compliance with Flourish Research's standards and federal regulations.

Requirements

• Prepare, maintain, and oversee all research-related regulatory documents
• Manage the full lifecycle of regulatory submissions to IRBs, sponsors, and regulatory agencies
• Submit study updates, including amendments, safety info, FDA 1572s, and consent forms
• Maintain accurate logs and ensure proper regulatory filing and archival of documents
• Prepare for monitoring visits and audits
• Distribute, collect, and track essential site regulatory documents (CVs, licenses, training certs, etc.)
• Maintain both paper and electronic regulatory files for all active studies
• Ensure confidentiality of study protocols and Protected Health Information (PHI)
• Draft clear, error-free written communications and documentation
• Execute duties safely, efficiently, and in alignment with company policies
• Represent Flourish Research professionally in all internal and external interactions
• Perform additional duties as assigned by management

Benefits

• Health, dental, and vision insurance plans
• 401k with 4% match
• Tuition reimbursement
• Parental leave
• Referral program
• Employee assistance program
• Life insurance
• Disability insurance
• 15 days of PTO + 10 company holidays