This job was posted by https://illinoisjoblink.illinois.gov : For moreinformation, please see:https://illinoisjoblink.illinois.gov/jobs/11604115 Department

　　BSD OCR - Office of Clinical Research

　　About the Department

　　The Office of Clinical Research (OCR) is dedicated to supporting theinfrastructure for the management and administration of clinicalresearch at The University of Chicago as well as individual researchprograms with the goal of improving communication, consistency, andcollaboration across the Biological Sciences Division and UChicagoMedicine.

　　To mission of the OCR is to catalyze clinical research by providingexpertise, resources, infrastructure, and systems that facilitateclinical research operations and enable collaboration across theenterprise while promoting compliance and human subject protection onbehalf of our diverse community of patients and volunteers.

　　The Research Compliance section provides oversight, resources andtraining for compliant conduct of clinical research, with focus onprocess improvement & customer service.

　　Job Summary

　　The job maintains regulatory compliance programs, including theinterpretation of systems to identify areas of risk and coordinateinternal audits. With a moderate level of direction, participates incompliance documentation and compliance training.

　　Responsibilities

　　Performs Clinical Research Compliance Audits.Conducts audits to document compliance with UChicago policies, GCP,Federal, state and local regulations.Provides written audit and investigation reports, identifying risksand recommendations for interventions to improve effectiveness andmitigate risk.Review all corrective action plans for identified deficiencies andtrack effectiveness of interventions for effectiveness and riskmitigation.Track and rend research compliance related allegations,investigations and outcomes.Performs Clinical Research Compliance Training & Education.Contributes to divisional clinical research training portfolio,training plans, coordination of speakers and frequency of modulesand topics.Trend and analyze effectiveness of training offerings.Serve as divisional subject matter expert regarding clinicalresearch compliance.Publish and maintain website with tools, templates and resourcesthat support divisional clinical research compliance.Provides Clinical Research Regulatory & Compliance Support.Provides support for ClinicalTrials.gov.Metrics Development and Reporting.Supports OCR initiatives by trending, tracking and setting targetsto measure impact of compliance activities.Collaborates with Clinical Research Stakeholders for projects acrossthe division focusing on increasing efficiencies and riskmitigation.Coordinates department or clinic compliance with a moderate level ofguidance.Plans and executes internal and external audits and activities tosupport regulatory agency inspections.Prepares, completes and submits all compliance documentation on aroutine basis. Coordinates compliance committee meetings.Performs other related work as needed.Minimum Qualifications

　　Education:

　　Minimum requirements include a college or university degree in relatedfield.

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　　Work Experience:

　　Minimum requirements include knowledge and skills developed through 2-5years of work experience in a related job discipline.

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　　Certifications:

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　　Preferred Qualifications

　　Education:

　　CITI Human Subject Protection & Good Clinical Practice.Experience:

　　Knowledge of Clinical Research Operations best practices.Knowledge of regulations governing human research, including 21 CFRParts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good ClinicalPractice guid lines.Ability to interpret research protocol information in relation tofederal guidelines and internal policies, exercise sound judgmentand make recommendations and/or decisions regarding researchpolicies.Familiarity with large healthcare information systems and/or pastexperience with EPIC experience.Technical Skills or Knowledge:

　　Demonstrable organizational and project management skills.Expertise in Microsoft Excel, Access, and PowerPoint.Preferred Competencies

　　Strong analytical, organizational and report writing skills.Excellent interpersonal and communication skills (oral/written).Ability to work as part of collaborative team as well asautonomously.Working Conditions

　　Office Environment.Application Documents

　　Resume (required)Cover Letter (preferred)