What are the responsibilities and job description for the Quality Assurance Specialist - Clinical Research position at Cook County Health & Hospitals System?
LOCATION: CLINICAL RESERARCH / LIFE SCIENCES DEPARTMENT - STROGER
SHIFT: 9AM-5PM
This position is exempt from Career Service under the CCH Personnel Rules.
Job Summary
The Quality Assurance Specialist, Clinical Research is responsible for identifying and analyzing clinical research key performance metrics, facilitating performance improvement activities, and ensuring compliance with all Federal, Local, Institution Review and Good Clinical Practice (GCP) standards. The Quality Assurance Specialist, Clinical Research will have direct involvement in improving the quality and compliance of clinical research activities through system risk assessments, auditing programs, and benchmarking reports of identified key performance indicators. Serves as a resource on quality assurance and clinical research, clinical trial monitoring and auditing procedures, and regulatory standards across Cook County Health (CCH).
General Administrative Responsibilities
- Review applicable Collective Bargaining Agreements and consult with Labor Relations to generate management proposals
- Participate in collective bargaining negotiations, caucus discussions and working meetings
- Document, recommend and effectuate discipline at all levels
- Work closely with labor relations and/or labor counsel to effectuate and enforce applicable Collective Bargaining Agreements
- Initiate, authorize and complete disciplinary action pursuant to CCH system rules, policies, procedures and provision of applicable collective bargaining agreements
- Direct and effectuate CCH management policies and practices
- Access and proficiently navigate CCH records system to obtain and review information necessary to execute provisions of applicable collective bargaining agreements
- Contribute to the management of CCH staff and CCH’ systemic development and success
- Discuss and develop CCH system policies and procedures
- Consistently use independent judgment to identify operational staffing issues and needs and perform the following functions as necessary; hire, transfer, suspend, layoff, recall, promote, discharge, assign, direct or discipline employees pursuant to applicable Collective Bargaining Agreements
- Work with Labor Relations to discern past practice when necessary
- 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 International 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
Minimum Qualifications
- High School Diploma with eight (8) years of clinical research experience or Bachelor’s degree from an accredited college or university with five (5) years of clinical research experience
- Three (3) years of quality, monitoring, and/or auditing research experience
- One (1) year of experience supervising and/or managing staff
- Working knowledge and experience with these federal regulations: GCP, 21 CFR 50, 21 CFR 312, and 21 CFR 812 compliance
- Proficiency with Microsoft Office (Word, PowerPoint, Excel)
- Must have one (1) or more of the following certifications:
o Association of Clinical Research Professionals (ACRP)
o Society of Clinical Research Associates (SoCRA)
o Quality Assurance
- Project Management experience and/or certification
- 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
- 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 plan, direct and integrate a complex operation using available resources to accomplish short- and long-term goals of the institution
- 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.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of the personnel so classified.
For purposes of the American with Disabilities Act, “Typical Duties” are essential job functions.
Benefits Package
- Medical, Dental, and Vision Coverage
- Basic Term Life Insurance
- Pension Plan
- Deferred Compensation Program
- Paid Holidays, Vacation, and Sick Time
- You may also qualify for the Public Service Loan Forgiveness Program (PSLF)
For further information on our excellent benefits package, please click on the following link: http://www.cookcountyrisk.com/
VETERAN PREFERENCE
PLEASE READ
When applying for employment with Cook County Health, preference is given to honorably discharged Veterans who have served in the Armed Forces of the United States for not less than 6 months of continuous service
To take advantage of this preference a Veteran must:
- Meet the minimum qualifications for the position.
- Identify self as a Veteran on the employment application by answering yes to the question by answering yes to the question, “Are you a Military Veteran?”
- Attach a copy of their DD 214, DD 215 or NGB 22 (Notice of Separation at time of application filing. Please note: If you have multiple DD214s, 215s, or NGB 22S, Please submit the one with the latest date. Coast Guard must submit a certified copy of the military separation from either the Department of Transportation (Before 9/11) or the Department of Homeland Security (After 9/11). Discharge papers must list and Honorable Discharge Status. Discharge papers not listing an Honorable Discharge Status are not acceptable
OR
A copy of a valid State ID Card or Driver’s License which identifies the holder of the ID as a Veteran, may also be attached to the application at time of filing.
If items are not attached, you will not be eligible for Veteran Preference
VETERANS MUST PROVIDE ORIGINAL APPLICABLE DISCHARGE PAPERS OR APPLICABLE STATE ID CARD OR DRIVER’S LICENSE AT TIME OF INTERVIEW.
MUST MEET ALL REQUIRED QUALIFICATIONS AT TIME OF APPLICATION FILING.
- Degrees awarded outside 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 must 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.
- CCH is strictly prohibited from conditioning, basing or knowingly prejudicing or affecting any term or aspect of County employment or hiring upon or because of any political reason or factor.
COOK COUNTY HEALTH IS AN EQUAL OPPORTUNITY EMPLOYER
Salary : $92,855 - $107,742
