Clinical Research Project Manager
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 Clinical Research Project Manager is an integral member of the Research Operations and Conduct group within the Office of Clinical Research (OCR). Under the direction of the Associate Director- ROC, the Clinical Research Project Manager will promote and facilitate a culture of compliance through education and training initiatives, regulatory support, quality assurance activities, and operational support and guidance in an effort to support adherence with Federal, State, and Local Regulations and Guidelines. This includes but is not limited to developing educational programming, providing divisional expertise on clinical trial project management and research operations, and supporting the clinical research conduct compliance program.
- Assist departments, sections and centers across the biological sciences division in improving and advancing clinical research operations and research infrastructure on an ad-hoc basis
- Work closely with other finance/billing/amendment ROC staff to support clinical research activities and amendment processes
- Act as an expert resource on appropriate use and management of data within electronic systems utilized for research administration and patient management (e.g., electronic medical record, IRB system, clinical trial management systems, etc.)
- Perform quality assurance and regulatory activities including, but not limited to: internal conduct audits, data quality audits, research billing audits, new study review, etc. to ensure quality control and compliance with guidelines as mandated by regulatory agencies (FDA, NIH, OHRP, CMS)
- Work with content experts to develop and provide training related to research regulatory management, research conduct, and financial management
- Produce high-quality educational and informational materials for a variety of audiences within the division and external to the organization
- Ability to work as part of collaborative team as well as autonomously
- 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
- Bachelor's degree required
- Certification by one of the Clinical Research Professional Organizations (SQA, SOCRA, ACRP) preferred
- A minimum of three years of clinical research conduct/ clinical research management 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
- Familiarity with large healthcare information systems and/or past experience with EPIC experience preferred.
- 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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