Advocate Health is the third-largest nonprofit, integrated health system in the United States, created from the combination of Advocate Aurora Health and Atrium Health. Providing care under the names Advocate Health Care in Illinois; Atrium Health in the Carolinas, Georgia and Alabama; and Aurora Health Care in Wisconsin, Advocate Health is a national leader in clinical innovation, health outcomes, consumer experience and value-based care. Headquartered in Charlotte, North Carolina. Services nearly 6 million patients and is engaged in hundreds of clinical trials and research studies. Wake Forest University School of Medicine serves as the academic core of the enterprise. Nationally recognized for its expertise in cardiology, neurosciences, oncology, pediatrics and rehabilitation, as well as organ transplants, burn treatments and specialized musculoskeletal programs. Employs 155,000 teammates across 69 hospitals and over 1,000 care locations. Offers one of the nation’s largest graduate medical education programs with over 2,000 residents and fellows across more than 200 programs. Committed to providing equitable care for all, Advocate Health provides more than $6 billion in annual community benefits.
Research Regulatory Specialist
Location
United States
Posted
2 days ago
Salary
Not specified
No structured requirement data.
Job Description
Role Description
This role involves supporting multiple complex clinical research studies, which may include:
- Multi-centered, cooperative group studies
- Single site studies
- Intergroup studies
- Industry studies
- Investigator-initiated studies
Key responsibilities include:
- Planning, developing, and preparing all required regulatory documents, including initial submissions, amendments, and continuing reviews to the IRB, FDA, OHRP, and other regulatory bodies.
- Supporting submissions to ancillary committees.
- Interfacing with relevant review boards and sponsors to resolve questions or issues regarding regulatory submissions.
- Collaborating with the Research Business Services Office for initial study submission, amendments, and closeout.
- Ensuring implementation of amendments, awareness of safety and protocol changes, and version control management.
- Acting as a liaison to investigators and research coordinators for reporting Adverse Events and noncompliance.
- Maintaining study level documentation and ensuring files are audit ready.
- Entering and maintaining study information and regulatory approvals in electronic systems.
- Providing guidance and training to research staff for compliance with regulations.
- Participating in quality improvement and quality assurance activities.
- Performing other duties as assigned.
Qualifications
- Bachelor's Degree (or equivalent knowledge) in Business or related field
- Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field
Requirements
- 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 related to regulatory documents.
- Knowledge of clinical trials and terminology.
- Excellent verbal and written communication skills.
- Strong organizational and time management skills.
- Ability to problem solve and work independently with high accuracy and attention to detail.
- Good understanding of computer software, including 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
- Educational Assistance Program
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 related to regulatory documents.
- Knowledge of clinical trials and terminology.
- Excellent verbal and written communication skills.
- Strong organizational and time management skills.
- Ability to problem solve and work independently with high accuracy and attention to detail.
- Good understanding of computer software, including 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
- Educational Assistance Program
