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Research Regulatory Specialist – NCCT
Location
Illinois + 2 moreAll locations: Illinois | North Carolina | Wisconsin
Posted
107 days ago
Salary
$30 - $46 / hour
Seniority
Senior
Job Description
Research Regulatory Specialist – NCCT
Advocate Aurora Health
• Supports multiple complex clinical research studies • Plans, develops and prepares all required regulatory documents • Supports submissions to ancillary committees • Interfaces with relevant review boards and sponsors to resolve questions or issues regarding regulatory submissions • Collaborates with the Research Business Services Office to assist with initial study submission, amendments and closeout • Acts as a liaison to investigators and research coordinators for reporting Adverse Events, noncompliance, and other FDA required reporting events • Maintains study level documentation for all studies • Ensure files are audit ready • Monitors compliance required documentation • Enters and maintains study information and regulatory approvals in electronic systems • Provides guidance and training to research staff to ensure compliance with highly complex regulations • Attends and participates in educational programs, meetings and assigned committees • Participates in the development and implementation of quality improvement and quality assurance activities
Job 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 and ICH GCP guidelines
- Knowledge of policies, procedures and SOPs specifically related to regulatory documents
- Knowledge of clinical trials and terminology required
- 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 a high degree of accuracy and attention to detail
- Good understanding of computer software such as Microsoft Office, Word, Excel, Adobe, and Teams
- Ability to travel between facilities as needed
Benefits
- Paid Time Off programs
- Health and welfare benefits such as medical, dental, vision, life, and Short- and Long-Term Disability
- Flexible Spending Accounts for eligible health care and dependent care expenses
- Family benefits such as adoption assistance and paid parental leave
- Defined contribution retirement plans with employer match and other financial wellness programs
- Educational Assistance Program
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