Regional Regulatory Specialist

Regional Regulatory Specialist Position: Regional Regulatory Specialist at Flourish Research site in Northridge, CA. Shift: Monday - Friday, 8 AM - 5 PM. Location: 18433 Roscoe Blvd #208, Northridge, CA 91325. Compensation: $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. 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. 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; 15 days of PTO + 8 paid holidays and 2 floating holidays. Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities. 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 Flourish Research