Location

Simpson Querrey Biomedical Research Center

Job Description

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:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

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

7. Assists in the management of external audits by regulatory agencies or business partners. Provides information and services to help research with FDA inspection readiness.

8. Other job functions as assigned.

Knowledge, Skills and Abilities:

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

2. 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.

3. 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).

4. 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.).

5. 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.

6. 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 quality issues.

7. Excellent oral and written communication skills; effectively communicates with all levels of the organization; good presentation and training skills.

8. Ability to perform multiple tasks with a high level of accuracy and attention to detail.

9. Proficient computer skills (Excel, Word, Outlook, Access, PowerPoint; electronic medical record (EPIC).

Education
Bachelor's Degree: Biomedical Science (Required)

Pay Range
$70,720.00-$115,627.20 Salary

At Lurie Children's, 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 Children's offer a comprehensive rewards package that may include differentials for some hourly employees, leadership incentives for select roles, health and retirement benefits, and wellbeing programs. For more details on other compensation, consult your recruiter or click the following link 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 Children's facilities
• Discount purchasing program