Research Regulatory Specialist – National Center for Clinical Trials

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🔥 49 minutes ago

🌽 Illinois, North Carolina – Remote

🌽 Illinois – Remote 🌲 North Carolina – Remote

💵 $30 - $46 / hour

⏰ Full Time

🟡 Mid-level

🟠 Senior

🔬 Research Analyst

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Advocate Aurora Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

💰 $10.2M Grant on 2019-08

Healthcare • Healthcare Insurance

Advocate Aurora Health is a leading healthcare organization that operates across various regions including Central Chicagoland, Central Wisconsin, Greater Milwaukee, and more. With a diverse range of career areas such as advanced practice clinicians, behavioral health, nursing, and more, Advocate Aurora Health is committed to helping people live well. The organization offers numerous benefits and opportunities for career advancement, fostering an environment where individuals can thrive and innovate in the healthcare sector. Advocate Aurora Health prioritizes the safety of its candidates and maintains a robust recruitment process to protect sensitive information.

📋 Description

• Provide direct regulatory support for NCCT clinical research studies • Prepare, review, and submit regulatory documents to IRB, FDA, OHRP, other regulatory bodies, ancillary committees, central cooperative-group offices, and sponsors • Coordinate and interface with regulatory bodies, industry representatives, investigators, research coordinators, and study team members • Support clinical research activity through timely submissions for new and ongoing studies • Resolve submission questions and issues to ensure timely review and approval • Collaborate on initial submissions, amendments, and study closeouts • Ensure implementation of amendments, safety and protocol-change awareness, and version control • Act as liaison for reporting adverse events, noncompliance, and other FDA-required events • Maintain study-level documentation and audit-ready files • Monitor compliance documentation • Enter and maintain study information and regulatory approvals in electronic systems • Provide guidance and training to research staff on complex clinical research regulations • 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; 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 during the work shift • Must have functional sight and hearing • Position may require travel

🏖️ Benefits

• Benefits Eligible: Yes • 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 • Well-being programs