Regional Regulatory Specialist

Flourish Research is looking for motivated, talented, creative individuals who want to learn and grow in their careers while contributing to research that changes lives! We offer an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. We are actively hiring a Regional Regulatory Specialist at the Flourish Research site in Northridge, CA! The Regulatory Specialist is responsible for managing and coordinating regulatory documents and activities for clinical research studies conducted at Flourish Research. This role involves working with site leadership, principal investigators, and regulatory bodies to ensure compliance with Flourish Research's standards, federal regulations, and sponsor protocols. Shift: Monday - Friday, 8 AM - 5 PM Location: 18433 Roscoe Blvd #208, Northridge, CA 91325 Compensation: Competitive Hourly Rate Benefits: Health, dental, and vision insurance plans, 401(k) with a 100% employer match on the first 4% of employee contributions, tuition reimbursement, parental leave, referral program, employee assistance program, life insurance, disability insurance, and 15 days of PTO + 8 paid holidays and 2 floating holidays.

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

QUALIFICATIONS

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 Meets or exceeds 80% of annual goals Excellent computer skills, including proficiency with Office365 Flourish Research is an equal employment opportunity employer. Employment decisions are based on merit and business needs, and not on race, color, sex, (including pregnancy and gender identity), citizenship status, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, genetic information, marital status, veteran status, political affiliation, or any other factor protected by law. Flourish Research complies with the law regarding reasonable accommodation for handicapped and disabled employees. #J-18808-Ljbffr Search Influence