Research Regulatory Specialist

aah; United States; Hybrid; USD 42,000 - 63,000; Full time

Benefits offered by this job

Paid Time Off

Health benefits

Flexible Spending Accounts

Educational Assistance Program

Retirement plan with employer match

Parental leave

Job summary

Advocate Health seeks a detail-oriented regulatory specialist to support complex clinical research studies and regulatory submissions. The role involves preparing regulatory documents, coordinating with IRB and FDA, and ensuring audit-ready records across single- and multi-site studies.

The candidate will collaborate with investigators and study teams, train staff on regulatory requirements, and support quality assurance activities.

Qualifications

• Bachelor's degree required in business or health care administration or related field.
• Typically 3 years of experience in research, clinical trials, and regulatory knowledge.
• Knowledge of FDA and DHHS regulations, ICH GCP guidelines, and Human Subject Protection rules.

Responsibilities

• Supports multiple complex clinical research studies, including multi-centered and industry studies.
• Prepares regulatory documents and continuing reviews for IRB, FDA, and other agencies.
• Coordinates regulatory submissions and maintains audit-ready study files.
• Interacts with review boards and sponsors to resolve regulatory questions and ensure timely approvals.
• Provides guidance to research staff on regulatory requirements and SOPs.
• Assists with study submissions and amendments and helps with quality assurance activities.

Skills

Regulatory knowledge

Regulatory submissions

Documentation

Verbal and written communication

Attention to detail

Problem solving

Travel ability

Education

Bachelor's Degree in Business or related field

Bachelor's Degree in Health Care Administration or related field

Tools

Microsoft Office

Excel

Word

Adobe

Teams

Job description

Department:

80041 Research - Clinical Trials Office

Status:

Full time

Benefits Eligible:

Yes

Hours Per Week:

40

Schedule Details/Additional Information:

Monday - FridayThis is a primarily remote position with some onsite work required.

Pay Range:

$30.70 - $46.05

Major Responsibilities:

Supports multiple complex clinical research studies, which may involve multi-centered, cooperative group studies, single site studies, intergroup studies, industry studies, and investigator-initiated studies.Plans, develops and prepares all required regulatory documents, including all initial, amendments and continuing reviews to the IRB, FDA, Office for Human Resource Protections (OHRP), and other regulatory bodies, including central offices of cooperative group studies, and sponsors where necessary. Supports submissions to ancillary committees.Interfaces with relevant review boards and sponsors to resolve questions or issues regarding regulatory submissions and ensure timely review and approval in compliance with local and external IRB SOPs and other regulatory agency requirements.Collaborates with the Research Business Services Office to assist with initial study submission, amendments and closeout.Collaborates with study team to ensure implementation of amendments, awareness of safety and protocol changes, and version control management.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, including those that are complex in nature. 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, highly specialized regulations and guidance associated with clinical research studies and trials involving human subjects. Attends and participates in educational programs, meetings and assigned committees.Participates in the development and implementation of quality improvement and quality assurance activities. Other duties as assigned.

Licensure, Registration, and/or Certification Required:

None Required.

Education Required:

Bachelor's Degree (or equivalent knowledge) in Business or related field.Bachelor's Degree (or equivalent knowledge) in Health Care Administration or related field.

Experience Required:

Typically requires 3 years of experience in research, clinical trials research and regulatory knowledge.

Knowledge, Skills & Abilities Required:

Knowledge of FDA and DHHS regulations and ICH GCP guidelines, Human Subject Protection rules and regulations related to regulatory documents.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 to accuracy and attention to detail.Good understanding of computer software, Microsoft Office, Word, Excel, Adobe, and TeamsAbility to travel between facilities as needed.

Physical Requirements and Working Conditions:

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.Exposed to a normal office environment.Position may require travel. May be exposed to road and weather hazards.

This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities required of the incumbent. Incumbent may be required to perform other related duties.

Our Commitment to You:

Advocate Health offers a comprehensive suite of Total Rewards: benefits and well-being programs, competitive compensation, generous retirement offerings, programs that invest in your career development and so much more - so you can live fully at and away from work, including:

Compensation

• Base compensation listed within the listed pay range based on factors such as qualifications, skills, relevant experience, and/or training
• 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

Benefits and more

• 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

Note: Eligibility for programs listed above may