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.

The Clinical Research Quality Assurance and Improvement (QA/QI) Specialist utilizes knowledge to 1) analyze and interpret applicable regulations, 2) develop/revise institutional policies and procedures, 3) audit the conduct of human subjects research (biomedical, social & behavioral) and research oversight programs, 4) assess compliance with all applicable regulations, guidances, and policies and procedures, 5) identify areas of risk, and 6) oversee the development and implementation of corrective and preventive action plans. Ensures adherence to the standards for the responsible conduct of research and compliance. Provides advice and expert knowledge to members of the human research protection program (HRPP). Assists with preparation for external quality reviews and regulatory audits.
Essential Job Functions

• Utilizes expert knowledge to analyze and interpret applicable regulations (federal and local laws, guidances, ICH -GCP, standards for accreditation, etc.), align, amend and enforce institutional policies and procedures and protect human research participants.

• Provides current and accurate compliance information and resources to the research community.

• Communicates regulatory changes, updates procedures according to best practices, and acts as a resource to colleagues and researchers in the area of research compliance.

• Evaluates compliance by planning and performing monitoring activities (i.e., routine and for-cause audits) in order to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., OHRP, FDA, etc.) and Good Clinical Practices (ICH-GCP).

• Develops and maintains quality assessment standards, tools, policies, and procedures needed to perform internal assessments of the conduct of clinical research at the institution.

• Documents detailed compliance findings and recommendations (with regulatory citations) in a timely manner that allows for proper review and assessment of the risks identified (including root cause analysis) and the conclusions drawn.

• Exercises appropriate judgment in evaluating audit findings, develops corrective and preventive action (CAPA) plans, provides targeted education and resources for resolution in a collegial and educational manner.

• Assists research teams in resolving issues and ensures responses and corrective and preventative action plans are implemented in a timely manner. Collects data on audit findings, prepares comprehensive reports (QA metrics) and analyzes trends to identify process failures and direct quality improvement and training initiatives.

• Presents data, trends, and risk assessments to the IRB and the Office of Research Integrity & Compliance.

• Works with Clinical Research Educator to develop and deliver educational offerings driven by audit findings (e.g. forms and checklists, educational training, regulatory advice/consultation, etc.) for investigators, research staff and other members of the HRPP to promote the responsible conduct of research and assists with site or study-specific self-assessments.

• Investigates compliance breaches, gathers relevant information, assesses impact, determines steps to mitigate risk, and reports findings.

• Assists in the management of external audits by regulatory agencies or business partners.

• Provides information and services to help research with FDA inspection readiness.

• Other job functions as assigned.

Job Qualifications

• Bachelor's degree in a related field required. Master's degree preferred.

• A minimum of 5 years substantive experience with Phase I though Phase III trials at the Clinical Research Coordinator or Research Compliance Coordinator (IRB Analyst) level; experience at Lurie Children's preferred. Two years of training or leadership experience preferred.

• 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 subjects research (ICH-GCP, OHRP, FDA regulations).

• Certification or eligibility to sit for Certification Exam in relevant area (i.e., Certified IRB Professional (PRIM&R), Certified Clinical Research Professional (SOCRA), Certified Clinical Research Coordinator or Associate (ACRP), Society for Quality Assurance and the American Society for Quality, etc.).

• 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 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).

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 affiliatesare 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.

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