Research Regulatory Specialist – National Center for Clinical Trials
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Job Description
Research Regulatory Specialist supporting IRB, FDA, and clinical-trial compliance for Advocate Health’s National Center for Clinical Trials. Preparing submissions, maintaining audit-ready records, and training research staff.
Responsibilities:
- Support multiple complex clinical research studies, including multi-site, single-site, industry, investigator-initiated, and real world data and evidence studies
- Prepare, review, and submit regulatory documents for initial submissions, amendments, and continuing reviews
- Submit documents to the IRB, FDA, OHRP, ancillary committees, cooperative group central offices, and sponsors
- Interface with review boards and sponsors to resolve regulatory submission questions and issues
- Collaborate with internal stakeholders on study submissions, amendments, and closeout
- Ensure implementation of amendments, awareness of safety and protocol changes, and version control
- Liaise with investigators and research coordinators for adverse event, noncompliance, and other FDA-required reporting
- Maintain study-level documentation and audit-ready files
- Monitor required compliance documentation
- Enter and maintain study information and regulatory approvals in electronic systems
- Provide guidance and training to research staff on clinical research regulations and guidance
- Participate in educational programs, meetings, committees, quality improvement, and quality assurance activities
- Contribute to SOP and compliance policy development
- Promote ethical research conduct
- Perform other duties as assigned
Requirements:
- Bachelor's Degree (or equivalent knowledge) in Business or related field
- Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field
- Typically requires 3 years of experience in research, clinical trials research, and regulatory knowledge
- Knowledge of FDA and DHHS regulations
- Knowledge of ICH GCP guidelines
- Knowledge of Human Subject Protection rules and regulations
- Knowledge of policies, procedures, and SOPs related to regulatory documents
- Knowledge of clinical trials and terminology
- Excellent verbal and written communication skills
- Organizational and time management skills, with ability to work under pressure and meet deadlines
- Ability to problem solve and work independently with accuracy and attention to detail
- Good understanding of Microsoft Office, Word, Excel, Adobe, and Teams
- Must be able to sit, stand, walk, lift, squat, bend, reach above shoulders, and twist frequently
- Must have functional sight and hearing
- Position may require travel
Benefits:
- Benefits Eligible
- Comprehensive suite of Total Rewards
- Premium pay such as shift, on call, and more based on a teammate's job
- Incentive pay for select positions
- Opportunity for annual increases based on performance
- Paid Time Off programs
- Medical, dental, vision, life, and Short- and Long-Term Disability benefits
- Flexible Spending Accounts for eligible health care and dependent care expenses
- Adoption assistance
- Paid parental leave
- Defined contribution retirement plans with employer match
- Other financial wellness programs
- Educational Assistance Program
- Career development programs
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