Regulatory Coordinator

Ann & Robert H. Lurie Childrens Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence kids and their families are at the center of all we do. Ann & Robert H. Lurie Childrens Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.

Coordinates and guides the review and approval process of all research activities associated with complicated clinical research studies involving human subjects in the Hematology Oncology and Stem Cell Transplantation Division ensuring the protection of their safety rights and welfare. Studies may be large nationwide or multiple moderately complex involving multiple sites and/or assessments/interventions. Interprets and applies rules and regulations (LCH local state federal industry sponsor etc.) and recommends and guides principal investigators (PIs) and research staff in the creation submission documenting reporting etc. of study activities ensuring appropriate compliance.

Job Responsibilities:

• Determines and interprets applicable rules and regulations associated with complex clinical research studies and trials involving human subjects ensuring the protection of their safety rights and welfare. Collaborates with the Office of Research Integrity and Compliance and Corporate Compliance to ensure ongoing compliance.
• Guides and coordinates all clinical trials-related submissions documentation and reporting processes (new study applications renewals revisions modifications amendments adverse events safety reports close-out etc.) recommending alternatives to ensure compliance and approval. Submits such documents to the IRB and other internal/external regulatory and oversight groups. Works with these groups to address any questions or concerns.
• Acts as a liaison between affiliate institutions study sponsors study coordinators investigators and appropriate oversight/regulatory agencies when questions issues problems arise regarding study status and process. Serves as a resource to the clinical research office staff on regulatory concepts.
• Researches new and updated rules and regulations associated with clinical research studies and trials involving human subjects. Provides guidance and training to research staff to ensure compliance with complex highly specialized rules and regulations associated with clinical research studies and trials involving human subjects. Creates and ensures submission of appropriate documents associated with new projects amendments adverse events informed consent revisions etc. to the IRB and other appropriate internal/external oversight groups.
• Determines compliance-required documentation and drafts necessary items such as protocols informed consent etc. Ensures accuracy of IRB approval letters with respect to sponsor information and NIH grant identifiers.
• Provides guidance and training to research staff to ensure compliance with complex highly specialized rules and regulations associated with clinical research studies and trials involving human subjects.
• Alerts appropriate staff to changes and ensures appropriate interpretation and application to new and existing studies and trials.
• Creates reports summaries and analysis in regard to compliance requirements recommending changes in practice or procedure to increase effectiveness and efficiency of compliance.
• Assists Division Administrator and/or Clinical Research Manager in maintaining departments research compliance program by ensuring adherence to all institutional policies and procedures federal state and other funding agency rules and regulations. Provides guidance and training to investigators and research support staff on applicable rules and regulations. Compliance program components include but are not limited to research safety effort reporting and conflict of interest reporting. 10. Other job functions as assigned.

Knowledge Skills and Abilities:

• Bachelors degree or the equivalent and three years of work experience in a regulatory and/or research environment having developed a strong working knowledge of clinical research protocols required.
• Detailed knowledge of federal state and local regulations and an in-depth understanding of ethical principles regarding the protection of human subjects in research. Working knowledge of local and federal regulations for human subject research (ICH-GCP OHRP FDA regulations).
• Excellent customer service project management and process improvement skills. Ability to take initiative prioritize tasks to meet deadlines produce results and cope with the inherent pressures.
• Excellent organizational and analytical skills: ability to apply sound judgment and take initiative in collection of information from a wide variety of sources; ability to identify and resolve issues.
• Excellent oral and written communication skills; effectively communicates with all levels of the organization; good presentation and training skills.
• Ability to perform multiple tasks with a high level of accuracy and attention to detail.
• Proficient computer skills (Excel Word Outlook Access PowerPoint; electronic medical record (EPIC).
• Ability to identify research and solve problems.

Education

Pay Range

At Lurie Childrens we are committed to competitive and fair compensation aligned with market rates and internal equity reflecting individual contributions experience and expertise. The pay range for this job indicates minimum and maximum targets for the position. Ranges are regularly reviewed to stay aligned with market conditions.In addition to base salary Lurie Childrens offer a comprehensive rewards package that may include differentials for some hourly employees leadership incentivesfor select roles health and retirement benefits and wellbeing programs. For more details on other compensation consult your recruiter or click the followinglink to learn more about our benefits.

Benefit Statement

For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes:

Medical dental and vision insurance

Employer paid group term life and disability

Employer contribution toward Health Savings Account

Flexible Spending Accounts

Paid Time Off (PTO) Paid Holidays and Paid Parental Leave

403(b) with a 5% employer match

Various voluntary benefits:

• Supplemental Life AD&D and Disability

• Critical Illness Accident and Hospital Indemnity coverage

• Tuition assistance

• Student loan servicing and support

• Adoption benefits

• Backup Childcare and Eldercare

• Employee Assistance Program and other specialized behavioral health services and resources for employees and family members

• Discount on services at Lurie Childrens facilities

• Discount purchasing program

Theres a Place for You with Us

At Lurie Childrens we embrace and celebrate building a team with a variety of backgrounds skills and viewpoints recognizing that different life experiences strengthen our workplace and the care we provide to the Chicago community and beyond. We treat everyone fairly appreciate differences and make meaningful connections that foster belonging. This is a place where you can be your best so we can give our best to the patients and families who trust us with their care.

Lurie Childrens and its affiliatesare equal employment opportunity employers. All qualified applicants will receive consideration for employment without regard to race color sex sexual orientation gender identity or expression religion national origin ancestry age disability marital status pregnancy protected veteran status order of protection status protected genetic information or any other characteristic protected by law.

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