Associate Director, Research Operations and Conduct
Hyde Park Campus
2010052 BSD - Office of Clinical Research
About the Unit
The Office of Clinical Research (OCR) was created to further the missions of the University of Chicago Biological Sciences Division and the University of Chicago Medical Center by developing and supporting specific infrastructure components related to clinical and translational research. To provide the highest level of support and resources, the Office of Clinical Research is divided into two groups- the Institutional Review Board Administrative Staff (IRB) and the Research Operations and Conduct group (ROC). The OCR focuses on six key areas of service including: Human Subject Protection (IRB); Training and Education; Regulatory and Contract Oversight; Quality Assurance/Reporting and Auditing; Financial/Billing Compliance; Institutional Infrastructure.
The Associate Director- Operations and Conduct is an integral member of the OCR team who will promote and facilitate a culture of compliance by providing instruction, support, and guidance to faculty/investigators, research staff, clinical staff and administrators in the performance of clinical research. The Associate Director – Operations and Conduct assists the Director of Research Operations and Conduct in establishing standards and best practices, developing and fulfilling standard operating procedures, policies and practices; coordinating system changes; implementing educational and training programs; developing communication tools; and managing the administrative functions that impact individuals involved in clinical research to ensure appropriate oversight of clinical research conduct, fulfillment of regulatory responsibilities, data integrity, and research billing compliance.
- Serves as a primary point of contact for faculty and research staff with regulatory, operational, and compliance questions or needs related to fulfilling their regulatory obligations and research program initiatives.
- Facilitate research staff and faculty in using systems to support research conduct and regulatory activities including the electronic medical record (Epic), clinical trial management system, data capture systems (e.g., RedCap), clinicaltrials.gov, IRB systems, etc.
- Proposes best practice guidelines, write standard operating procedures, distribute educational material, and provide training in order to promote understanding and adherence of clinical research regulations and responsibilities, local policies, and best practices.
- Manage quality assurance activities within the research operations and conduct (ROC) team to ensure adequate quality control measures and documentation of processes and quality assurance guidelines as mandated by regulatory agencies (FDA, NIH, OPHR) are met.
- Work closely with IRB administrative staff, ROC staff and OCR leadership to facilitae and manage clinical research oversight and support activities such as, but not limited to, new study review, creation of study records into electronic systems, amendments, clinicaltrials.gov, etc.
- Perform quality assurance activities including, but not limited to: internal conduct audits, data quality audits, research billing audits, etc. to ensure quality control and compliance with guidelines as mandated by regulatory agencies (FDA, NIH, OHRP, CMS).
- Produce, analyze, and distribute reports to departmental research leaders and research staff to communicate current compliance with internal policies and procedures; manage status of required actions in order to improve data quality, system usage, and workflow.
- Ability to work with minimal supervision and function as a team member required.
- Demonstrated accuracy and precision and attention to detail
- Strong organizational and project management skills
- Expertise in Microsoft Excel, Access, and PowerPoint
- Excellent written and verbal communication skills, including presentation skills
Education, Experience and Certifications:
- Bachelor's degree required
- Certification by one of the Clinical Research Professional Organizations (SQA, SOCRA, ACRP) preferred
- Minimum of five years of clinical research management or clinical research compliance experience required
- Advanced knowledge of regulations governing human research, including 21 CFR Parts 11, 50, 54, 56, 312 and 812, 45 CFR 46, and ICH Good Clinical Practice guidelines required
- Ability to interpret research protocol information in relation to federal guidelines and internal policies, exercise sound judgment and make recommendations and/or decisions regarding research policies required
- Ability to manage large quantities of data in a manner which facilitates sharing of information and reporting of key performance indicators and metrics
- Cover Letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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