Clinical Research Regulatory Coordinator

Clinical Research Regulatory Coordinator

AIH Research - Advancing Health Through Innovation

Join a mission-driven research team transforming access to clinical trials for diverse and underserved communities. AIH Research partners with Community Health Network to bring FDA-approved studies to patients who need them most-improving health equity while delivering high-quality data to sponsors.

We're seeking a Clinical Research Regulatory Coordinator who's sharp, organized, and passionate about compliance, quality, and moving research forward.

REQUIRES ON-SITE WORK
What You'll Do

• Lead and manage regulatory operations across multiple clinical trials
• Ensure full compliance with ICH GCP, FDA regulations, and ethical standards
• Maintain IRB/CLIA/IBC submissions, regulatory binders, CVs, training logs & site certifications
• Oversee quality assurance, conduct internal audits, support sponsor inspections
• Manage regulatory language for marketing materials
• Maintain and update SOPs; support continuous process improvement
• Oversee feasibility submissions and track study startup milestones
• Support the Associate Director with additional regulatory projects

What You Bring

• Deep knowledge of GCP, human subject protections, and FDA trial regulations
• Experience with eReg, CTMS, EDC systems, and strong Microsoft Office skills
• Ability to manage complex regulatory workflows with precision and independence
• Associate degree in clinical research, nursing, or related field
• 3-5 years clinical research experience + 2-3 years regulatory experience
• Bachelor's degree preferred
• Clinical research certification preferred (CCRP, CCRC, ACRP-CP)
• Feasibility and SOP experience preferred

Why You'll Love Working With Us:

• 100% Paid Employee Health & Dental Insurance.
• Paid Time Off + Birthday Leave + Sick Time.
• $200 Annual CE Stipend.
• Career Growth & Flexible Schedules.
• Make a Real Impact in Underserved Communities.

Work schedule

• 8 hour shift
• Monday to Friday

Benefits

• Flexible schedule
• Paid time off
• Health insurance
• Dental insurance
• Vision insurance
• Life insurance
• Disability insurance
• Referral program
• Employee discount
• Pet rider program
• Mileage reimbursement
• Other