• Manages quality assurance activities across CCH clinical research operations

• Analyzes and measures collected data, such as, quality assurance data and customer feedback data, as part of monitoring for continuous improvement. Designs, plans, and delegates new clinical research initiatives

• Implements and ensures efficient processes for research activities by monitoring effectiveness and fiscal integrity

• Provides strategic leadership and ensures alignment of policies and procedures to technology systems i.e., bioinformatics, data integration, EHR data extraction

• Reviews and updates departments policies and procedures, including protecting the privacy of research participants

• Understands and maintains current knowledge of federal and local standards and regulations. Communicates regulatory changes, updates procedures according to best practices

• Provides current and accurate research compliance information and resources to the research community. Evaluates research compliance by planning and performing monitoring activities (i.e., routine and for-cause audits) to assess risk and ensure adherence to institutional policies and procedures, local and federal regulations (i.e., Office for Human Research Protections (OHRP), Food and Drug Administration (FDA), etc.) and Conference on Harmonization and Good Clinical Practices (ICH-GCP)

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

• 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 Institutional Review Board (IRB) and the Office of Research Integrity & Compliance

• Performs comprehensive clinical research records reviews to identify quality of research documentation and compliance, risks, and compile inspection reports

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

• Drafts the clinical research monitoring and auditing plans. Reports on results and trends based on findings for clinical research compliance

• Reviews and present audit findings

• Acts as a liaison to research leadership to support managing research portfolios

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

• Facilitates development of quality metrics, guides development of clinical research dashboards and assists in tracking and trending data

• Analyzes trends of performance metrics, identifies opportunities for improvement, and develops action plans

• Collaborates with and trains staff to implement monitoring and measurement tools, and data analysis techniques

• Facilitates quality efforts and coaches others in the development of performance improvement activities with an emphasis on process redesign and measurement

• Conducts root cause analysis (RCA) to proficiently facilitate clinical research efforts and group discussion

• Aids in the development of Corrective and Preventive Action (CAPA) planning and tracking to follow all non-conformities to resolution

• Performs other duties as assigned

• Bachelor's degree from an accredited college or university or higher (MUST PROVIDE OFFICIAL TRANSCRIPTS AT TIME OF INTERVIEW)

• Three (3) years of relevant clinical research experience

• Two (2) years of quality, monitoring, and/or auditing research experience

• One (1) year supervising and/or managing staff

• Proficiency with Microsoft Office (Word, PowerPoint, Excel)

• Professional Research certification (i.e., SOCRA, ACRP)

• Society of Quality certification

• Project Management experience and/or certification

• Working knowledge of GCP, GMP, GLP, 21 CFR 50, 21 CFR 312 and 21 CFR 812 compliance

• Knowledge of Lean / Six Sigma and / or ISO 9001 concepts

• Excellent verbal, written communication, and interpersonal skills necessary to communicate with all levels of staff and a patient population composed of diverse cultures and age groups. Persuasive communications skills to support role as an internal change agent and to strengthen working relationships with external stakeholders

• Mentoring skills for developing core grant administration competencies across CCH operating units

• Ability to plan, direct and integrate a complex operation using available resources to accomplish short- and long-term goals of the institution

• Excellent presentation and team-building skills

• Strong qualitative, quantitative, analytic, and critical thinking and organizational problem-solving skills

• Detail-oriented and have high standards of accuracy

• Ability to prioritize, plan, and organize projects and tasks to meet deadlines in a fast-paced and stressful environment

Physical and Environmental Demands

This position is functioning within a healthcare environment. The incumbent is responsible for adherence to all hospital and department specific safety requirements. This includes but is not limited to the following policies and procedures: complying with Personal Protective Equipment requirements, hand washing and sanitizing practices, complying with department specific engineering and work practice controls and any other work area safety precautions as specified by hospital wide policy and departmental procedures.

MUST MEET ALL REQUIRED QUALIFICATIONS AT TIME OF APPLICATION FILING.

*Degrees awarded outside of the United States with the exception of those awarded in one of the United States' territories and Canada must be credentialed by an approved U. S. credential evaluation service belonging to the National Association of Credential Evaluation Services (NACES) or the Association of International Credential Evaluators (AICE). Original credentialing documents bust be presented at time of interview.

*Please note all offers of Employment are contingent upon the following conditions: satisfactory professional & employment references, healthcare and criminal background checks, appropriate licensure/certifications and the successful completion of a physical and pre-employment drug screen.

*CCHHS is strictly prohibited from conditioning, basing or knowingly prejudicing or affecting any term or aspectof County employment or hiring upon or because of any political reason or factor.

COOK COUNTY HEALTH & HOSPITALS SYSTEM IS AN EQUAL OPPORTUNITY EMPLOYEE