Clinical Research Compliance Specialist

Flourish Research; Chicago (IL); On-site; USD 49,920 - 58,240; Full time

Benefits offered by this job

Health, dental, and vision insurance

401(k) with employer match

Tuition reimbursement

Parental leave

PTO and holidays

Job summary

Flourish Research in Chicago, IL is seeking a Regulatory Compliance Specialist for our Andersonville site. The role is on-site, with a Monday–Friday day shift (40 hours/week), Non-Exempt under FLSA. You will manage regulatory documents, IRB submissions, and ongoing compliance across study lifecycles.

Required: Bachelor's degree or equivalent experience and at least 3 years in clinical/biological research. Strong MS Office skills, attention to detail, and excellent communication are essential to

Qualifications

• Bachelor's degree or equivalent experience
• Minimum of 3 years' experience in clinical or biological research
• Strong knowledge of regulatory documents and HIPAA

Responsibilities

• Prepare and oversee regulatory documents for research
• Submit regulatory documents to IRB and sponsors
• Compile study information and reports to IRB/sponsor
• Prepare submission forms and updates (Amendments, Investigator's Brochures, FDA forms)
• Maintain regulatory logs
• Assist archival of clinical trial records
• Prepare for monitoring visits and audits
• Manage CVs and licenses for employees
• Comply with HIPAA and safeguard confidentiality
• Create clear written documents and reports
• Represent Flourish Research professionally

Skills

Regulatory compliance

Clinical research

MS Office

Attention to detail

Communication skills

Education

Bachelor's degree or equivalent experience

Tools

Microsoft Office (Outlook, Word, Excel)

Job description

Flourish Research in Chicago, IL is seeking a Regulatory Compliance Specialist for our Andersonville site. The role is on-site, with a Monday–Friday day shift (40 hours/week), Non-Exempt under FLSA. You will manage regulatory documents, IRB submissions, and ongoing compliance across study lifecycles.

Required: Bachelor's degree or equivalent experience and at least 3 years in clinical/biological research. Strong MS Office skills, attention to detail, and excellent communication are essential to