Clinical Research Quality Assurance and Improvement Specialist

Ann & Robert H. Lurie Children's Hospital of Chicago•Chicago, IL

4d•Onsite

About The Position

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.

Requirements

Bachelor's degree in a related field required.
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.
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).

Nice To Haves

Master's degree preferred.
Two years of training or leadership experience preferred.

Responsibilities

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.

Benefits

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