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Regulatory Research Specialist

4 months ago

Lisle, United States Ascension Full time

We Are Hiring:

- **Department**: Research
- ** Schedule**: Full Time, Day Shifts
- ** Hospital**: Ascension Alexian Brothers
- ** Location**:Elk Grove Village, Illinois

What You Will Do:
Create and submit all required regulatory submissions related to research studies conducted by the organization.
- Coordinate, prepare, review, and submit required regulatory documentation.
- Review and recommend changes to departmental policies, procedures and standards commensurate with regulatory developments.
- Review and research pertinent trends, issues, and developments in research and disseminates information to staff.
- Maintain regulatory references and materials.

What You Will Need:
Licensure / Certification / Registration:

- Research Professional preferred.

**Education**:

- High School diploma equivalency with 2 years of cumulative experience OR Associate's
degree/Bachelor's degree OR 4 years of applicable cumulative job specific experience required.

Additional Preferences:
Additional preferences.

Manages and maintains electronic regulatory files (e.g., staff resumes, licenses, training

certificates, equipment receipts, investigation logs).

Reviews documentation as needed to support regulatory filings, and maintains research files

and documentation required by regulations.

Submits protocols and supporting documents to internal and external regulatory bodies (i.e.,

Institutional Review Board), ensuring trials are consistent with approved proposals to open new

studies.

Reviews and modifies Informed Consent documents to reflect the Ascension Illinois mission.

Attends all study initiation, (remote or onsite) monitoring, and close out visits.

Supports multiple complex clinical research studies, which may involve multi-centered,

cooperative group studies, single site 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, and other regulatory bodies.

Serves as a liaison between the site and sponsor 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.

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

assigned committees.

Why Join Our Team:
Ascension Illinois delivers compassionate, personalized care throughout Chicago and its surrounding suburbs. As one of the largest health systems in Illinois with 15 hospitals and more than 230 sites of care, you will find an environment that allows you to thrive and create a career path you love. Join a diverse team of more than 17,000 associates and more than 600 providers who are dedicated to providing compassionate, personalized care to all.

Ascension is a leading non-profit, faith-based national health system made up of over 134,000 associates and 2,600 sites of care, including more than 140 hospitals and 40 senior living communities in 19 states.

Our Mission, Vision and Values encompass everything we do at Ascension. Every associate is empowered to give back, volunteer and make a positive impact in their community. Ascension careers are more than jobs; they are opportunities to enhance your life and the lives of the people around you.

Equal Employment Opportunity Employer:
Ascension will provide equal employment opportunities (EEO) to all associates and applicants for employment regardless of race, color, religion, national origin, citizenship, gender, sexual orientation, gender identification or expression, age, disability, marital status, amnesty, genetic information, carrier status or any other legally protected status or status as a covered veteran in accordance with applicable federal, state and local laws.

For further information, view the EEO Know Your Rights (English) poster or EEO Know Your Rights (Spanish) poster.

Pay Non-Discrimination Notice

E-Verify Statement:
This employer participates in the Electronic Employment Verification Program. Please click the E-Verify link below for more information.

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**Benefits**:
Paid time off (PTO)

Various health insurance options & wellness plans

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