Clinical Trials Regulatory Specialist

Advocate Aurora Health; Charlotte (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Advocate Health is seeking a Research Regulatory Coordinator to support regulatory submissions, budget management, and data coordination for clinical trials. The role partners with PIs and research staff to maintain audit-ready files and ensure compliance with GCP and SOPs.

The candidate should have a Bachelor’s degree in a relevant field and at least two years of research coordination experience; SOCRA/ACRP certification is preferred, with CITI training required or to be completed.

Qualifications

• Bachelor's degree or higher; clinical research coordination experience required
• Experience coordinating regulatory documentation and data management in trials
• SOCRA/ACRP optional; CITI certification preferred; WakeOne training encouraged

Responsibilities

• Assist with ensuring compliance with SOPs and GCP, and support regulatory submissions
• Support inspections, audits, and monitors visits; maintain audit-ready files
• Prepare protocol documents, consent forms, and regulatory submissions through OnCore (WISER)
• Build protocol calendars in OnCore (WISER) and track protocol status
• Assist in budget preparation and financial tracking for studies
• Enter study activities into databases and resolve data queries with staff
• Manage study closure activities and archive study records
• Participate in team meetings and provide staff relief when needed
• Maintain confidentiality and uphold integrity in all activities

Skills

Interpersonal communication

Oral communication

Written communication

Active listening

Attention to detail

Prioritization

Multitasking

Microsoft Office

OnCore implementation

Reading comprehension

Confidentiality

Education

Bachelor's degree in Education, Public Health, Basic Science, or relevant clinical discipline

Two years of research coordination/data management experience

Master's degree preferred

Budget/financial tracking experience preferred

Tools

EPIC/WakeOne

OnCore (WISER)

Microsoft Office Suite

Job description

Advocate Health is seeking a Research Regulatory Coordinator to support regulatory submissions, budget management, and data coordination for clinical trials. The role partners with PIs and research staff to maintain audit-ready files and ensure compliance with GCP and SOPs.

The candidate should have a Bachelor’s degree in a relevant field and at least two years of research coordination experience; SOCRA/ACRP certification is preferred, with CITI training required or to be completed.