Regional Regulatory Specialist

Flourish Research is a clinical trial organization focused on diverse therapeutic areas. We are actively hiring a Regional Regulatory Specialist at our Northridge, CA site. Location & Schedule 18433 Roscoe Blvd #208, Northridge, CA 91325 Monday – Friday, 8 AM – 5 PM Compensation & Benefits Competitive hourly rate. Health, dental, and vision insurance 401(k) with 100% employer match on the first 4% of employee contributions Tuition reimbursement Parental leave Employee assistance program Life and disability insurance 15 days of paid time off, 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 certificates, etc.). Maintain both paper and electronic regulatory files for all active studies. Ensure confidentiality of study protocols and PHI. Draft clear, error‑free written communications and documentation. 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. Professionalism and strong 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 Office 365. EEO Statement 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