Regulatory Specialist

About Flourish Research

Flourish Research is a leading clinical trials organization specializing in cardiology, metabolic disorders, renal, CNS, pulmonology, and vaccines. The company is committed to excellence by ensuring equitable care for people of all backgrounds, fostering diversity and inclusion among employees, patients, and customers. Flourish Research promotes a safe, respectful, and inclusive work environment driven by a diverse and passionate team dedicated to improving global community health.

Role Overview

We are seeking a Regional Regulatory Specialist to join our Northridge, CA site. This role entails managing and coordinating regulatory processes and documentation related to clinical research studies. The person will work closely with site leadership, principal investigators, and regulatory entities to guarantee adherence to company policies, federal guidelines, and sponsor protocols.

Work Schedule and Location

This is a full-time position, Monday through Friday, 8:00 AM to 5:00 PM, located at 18433 Roscoe Blvd #208, Northridge, CA 91325.

Compensation

The hourly pay ranges from $25 to $26 for entry-level candidates, with possible adjustment based on directly relevant previous clinical research or regulatory experience.

Core Responsibilities

• Organize and maintain comprehensive regulatory documents associated with research studies.
• Coordinate the complete cycle of regulatory submissions to Institutional Review Boards (IRBs), sponsors, and regulatory agencies.
• Submit updates such as amendments, safety information, FDA 1572 forms, and consent form revisions.
• Keep accurate logs and ensure regulatory documentation is properly filed and archived.
• Prepare materials and documentation for monitoring visits and audits.
• Manage the collection and distribution of essential regulatory documents (e.g., CVs, licenses, training certifications).
• Maintain regulatory files in both paper and electronic formats for all ongoing studies.
• Protect the confidentiality of study protocols and sensitive health data.
• Create clear, precise, and error-free written communications.
• Perform duties safely, efficiently, and in compliance with company policies.
• Effectively represent Flourish Research in all internal and external communications.
• Handle additional responsibilities as assigned by management.

Candidate Requirements

• High school diploma or equivalent required; preference for candidates with a college degree.
• Experience ranging from none to three or more years in clinical or biological research is acceptable.
• Proficiency in Microsoft Office (Outlook, Word, Excel) and familiarity with CTMS, eRegs, or eDocs platforms.
• Strong attention to detail, organization skills, and self-motivation.
• Ability to work independently as well as collaboratively in a fast-paced environment.
• Excellent written and verbal communication skills.
• Exhibit professionalism and ethical conduct in interactions with patients, sponsors, IRBs, and staff.
• Critical thinking and effective problem-solving capabilities.
• High level of professionalism and dedication to work.
• Flexibility to accept additional responsibilities as needed.
• Experience collaborating cross-departmentally and resolving issues.
• Contribute to initiatives aimed at improving departmental processes.
• Assist with training new team members.
• Meet or exceed 80% of annual performance goals.
• Strong computer skills including proficiency with Office365.

Benefits

• Comprehensive health, dental, and vision insurance coverage.
• 401(k) plan with employer match of 100% on the first 4% of employee contributions.
• Tuition reimbursement program.
• Parental leave benefits.
• Referral incentives.
• Employee assistance program.
• Life and disability insurance plans.
• Paid time off including 15 days of PTO, 8 paid holidays, and 2 floating holidays.

Equal Opportunity Statement

Flourish Research is an equal opportunity employer committed to hiring based on merit and business needs without discrimination based on race, color, sex (including pregnancy and gender identity), citizenship, national origin, ancestry, gender identity, sexual orientation, age, religion, creed, disability, genetic information, marital status, veteran status, political affiliation, or other protected factors. The company complies with laws providing reasonable accommodation for disabled employees.