Regional Regulatory Specialist

About Us:

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.

At Flourish Research, we strive toward excellence. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status. We embrace employees, customers, and patients from these underrepresented groups to help make this vision a reality. Flourish Research is driven by a diverse and inclusive community of passionate people who are committed to improving the quality of life of communities around the world. Flourish is committed to a safe work environment where all employees, customers, and patients are included, and treated with dignity and respect.

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: $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