Regional Regulatory Specialist

Flourish Research; Milwaukee (WI); On-site; USD 34,440 - 35,817; Full time

Benefits offered by this job

Health insurance

401(k) with employer match

Job summary

Flourish Research is seeking a Regulatory Specialist to manage regulatory documents for clinical trials at our Northridge site. You will coordinate with site leadership and investigators to ensure compliance with regulations and sponsor protocols.

Responsibilities include preparing regulatory submissions, maintaining files, and ensuring readiness for audits. Entry-level compensation is $25-$26/hour, with room for growth based on relevant experience and performance.

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.

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.

Skills

MS Office

Strong written and verbal коммуникация

Detail-oriented

Independent and collaborative

Critical thinking

Education

High school diploma or equivalent

College degree preferred

Tools

CTMS

eRegs/eDocs

Office365

Job description

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

• 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 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.