Lurie Children’s Hospital

Ann & Robert H. Lurie Children’s 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 Children’s Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report.

Location

Simpson Querrey Biomedical Research Center

Job Description

Assists in the managing of the day-to-day operations and processes of the research compliance committees as assigned, including but not limited to the Institutional Review Board (IRB) and the Institutional Biosafety Committee (IBC). Provides oversight over the processes and activities of the Research Compliance Coordinators. Works with the Director, ORIC on compliance related activities such as accreditation and general department administration.

Essential Job Functions:

Leadership Accountabilities

Clinical Quality Outcomes:

• Establishes and maintains high standards for quality of care, & patient safety.
• Takes initiative to improve both processes and outcomes, incorporating best practices, and innovations in professional field.
• Ensures compliance with Lurie Children’s policies and all accreditation & regulatory bodies and their standards.

Strategic Growth:

• Compellingly communicates to staff the critical role they play in achieving Lurie Children’s mission and strategic goals.
• Facilitates organizational change initiatives; leads and supports staff in adapting to a rapidly changing health care environment.
• Facilitates development and achievement of professional & personal goals for self and staff.
• Effectively recruits, orients, develops & retains a talented and diverse workforce.

Brand Identity:

• Strengthens our brand as a top tier provider and employer by establishing and maintaining high standards for excellence.
• Models our values of service, innovation and teamwork. Holds others accountable for living these values.
• Fulfills the Employee Promise by fostering a challenging & compassionate work environment, recognizing strong performance, and listening and acting on feedback.

Customer Satisfaction:

• Consistently models our Service Principles in internal and external interactions and ensures that the Service Principles are fulfilled to by others.
• Ensures employees receive information needed to perform jobs including feedback to enhance performance and customer satisfaction.
• Proactively addresses performance issues when indicated and administers policies, decisions, & disciplinary actions with consistency.

Financial Performance:

• Aligns department goals and manages department resources and budgets to meet Lurie Children’s strategic objectives.
• Helps others understand the drivers of financial success for department and Lurie Children’s.

Area Specific Job Accountabilities

• Provides consultation (ORIC staff, committee chairs, committee members, investigators, research staff, etc.) on application of DHHS, FDA and other applicable regulations and statutes for the protection of human subjects to specific research situations.
• Trains and supervises ORIC staff as assigned. Exercises independent judgement and provides recommendations/input on hiring, firing, promotions, demotions to direct reports, including revision of job descriptions when necessary.
• Evaluates performance of direct reports mid-year and annually. Ensures that Federalwide Assurances, IRB Registrations, and IBC registrations are maintained.
• Ensures that compliance committee rosters are maintained in a current and accurate manner in consistency with applicable requirements.
• Works with chairs to implement membership changes, ensuring that constitution of each board meets regulatory and institutional requirements.
• Participates in annual evaluation of committee chairs and members. Ensure that research compliance committee meetings are scheduled and posted in a timely manner. 
• Collaborates in the development and ongoing review/development of policies and procedures and standard operating procedures for assigned committee(s). Conducts quality assurance assessments to steer quality improvement initiatives including the periodic review of: 1) Timeliness of reviews; 2) Quality of reviews;; 3) Analysis of metrics;; 4) IRB meeting minutes; 5) Staff pre-reviews of protocol submissions.
• Coordinates and implements complex projects including the implementation and maintenance of the electronic IRB system.
• Leads quality improvement initiatives and special projects designed to enhance office procedures, IRB performance, biosafety, and/or overall human subjects protections. Interfaces with researchers to improve processes or assess concerns, striving to maintain a collaborative relationship to facilitate the shared goal of conducting ethical human research. 
• Conducts related education/training as needed.
• Represents ORIC on institutional committees and workgroups which focus on issues relating to research compliance and/or human subjects protections. 
• Works with the Director and ORIC staff in preparing and maintaining applicable accreditations (i.e., AAHRPP).
• Oversees and manages the processes and staff to support the research compliance committees’ functions including minutes, agendas, and other correspondence.
• Responsible for working with staff in compiling and writing of minutes.
• Ensures that IRB meeting minutes are being processed in a timely manner and in compliance with regulatory requirements.
• Leads development and execution of interinstitutional IRB authorization (reliance) agreements, outlining key responsibilities of each entity.
• Supports the Director, Office of Research Integrity and Compliance (ORIC), on other regulatory and assurance issues. Serves as a back-up to the Director, ORIC, as needed.
• Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients, families, co-workers and others.

Knowledge, Skills and Abilities:

• Bachelor’s Degree (unspecified area).
• A master’s degree in a relevant field is preferred.
• Minimum of three years of progressively responsible research administration or regulatory review committee experience in a hospital, university or other research setting.
• Demonstrated strong leadership skills.
• Strong interpersonal skills necessary to interact and communicate effectively with physicians, Principal Investigators, and medical center personnel, and external funding agencies, and to maintain a variety of internal and external contacts.
• Excellent command of the English language.
• Ability to establish priorities and react promptly to a large variety of requests and needs, sometimes in stressful situations.
• Demonstrated knowledge of Microsoft Office and other computer software is required.
• Experience in accreditation activities, such as AAHRPP, is preferred.
• Certified IRB Professional (CIP) or similar certification is preferred.

Education

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 Children’s facilities
• Discount purchasing program

There’s a Place for You with Us

At Lurie Children’s we embrace and celebrate diversity and equity in a serious way. We are committed to building a team with a variety of backgrounds, skills, and viewpoints — recognizing that diverse identities strengthen our workplace and the care we can provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging and allyship. 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 Children’s and its affiliates are equal employment opportunity employers. We value diversity and are committed to creating an inclusive environment for all employees. 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.

Support email: candidatesupport@luriechildrens.org