Regulatory Specialist

About the Role

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.

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

Requirements

• 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

Schedule

Monday - Friday, 8 AM - 5 PM

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.

Benefits

Flourish Research offers an excellent comprehensive benefits package, a supportive and collaborative work environment, and endless growth opportunities.

• 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