Regional Regulatory Specialist

About the role

Flourish Research represents is of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.

We are actively hiring a Regional Regulatory Specialist at the Flourish Research site in Northridge, CA!

Responsibilities

• 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

Requirements

• High school diploma or equivalent required; college degree preferred
• 0–3+ years of experience in clinical or biological research
• Proficient in Microsoft Office (Outlook, Word, Excel) and platforms such as CTMS, eRegs/eDocs
• Highly detail-oriented, organized, and self-motivated
• Able to work independently and collaboratively in a fast-paced environment
• Strong written and verbal communication skills
• Ethical and professional in interactions with patients, sponsors, IRBs, and staff
• Strong critical thinking and problem-solving abilities
• Demonstrates a high level of professionalism and work ethic
• Flexible and willing to take on additional tasks as needed
• Effective at cross-departmental collaboration and issue resolution
• Contributes to departmental initiatives and process improvements
• Assists in training new team members
• Mets or exceeds 80% of annual goals
• Excellent computer skills, including proficiency with Office365

Benefits

• Health, dental, and vision insurance plans
• 401(k) with a 100% employer match on the first 4% of employee contributions
• Tuition reimbursement
• Parenthood leave
• Referral program
• Employee assistance program
• Life insurance
• Disability insurance
• 15 days of PTO + 8 paid holidays and 2 floating holidays

Pay

$25-$26/hour for entry-level candidates, with potential flexibility for candidates with directly relevant clinical research, regulatory, healthcare administration, or other highly applicable experience.

Schedule

Monday - Friday, 8 AM - 5 PM