Clinical Research Coordinator II

* Develop study protocols, CRFs, and other study documents.
* Develop instructional regulatory body (IRB) protocols, amendments and other documents as well as respond to IRB stipulations and requirements.
* Collect, archive subjects’ data. Assist in scientific data dissemination. Develop, write, edit, submit and publish scientific manuscripts and present scientific abstract at national and international conferences.
* Participate in local and national meetings related to multi center trials and participate in regular phone/skype meetings related to clinical research.
* Assist in developing and submitting regular progress reports to NIH and other sponsors of clinical research studies.
* This job provides technical and administrative support in a laboratory environment performing basic laboratory techniques, research and analysis under direction.
* Provides routine or standardized laboratory duties by collecting data in support of research projects under direct supervision.
* Collects and enters data. Assists in analysis of data and with preparation of reports, manuscripts and other documents.
* Complies with institution, state and federal regulatory policies, procedures, directives, and mandates.
* Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, subject consenting, subject recruitment, perform and supervise various study visit procedures, and participation in program audits.
* Prepares program conference lists for multidisciplinary conferences and workshops.
* Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
* Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
* Interprets the data needed for insurance submissions. Gathers pre-testing results if obtained at an outside facility.
* Accountable for all tasks in moderately complex clinical studies.
* Facilitates and participates in the daily activities of moderately complex clinical studies and performs various activities including patient data retrieval, documenting clinical research records, and participation in program audits.
* Performs other related work as needed.
* Previous clinical trials experience.
* Previous IRB protocol experience.
* Organization.
* Problem-solving.
* Collaboration.
* Attention to detail.
* Ability to work autonomously.
* Proficiency in Microsoft Office, including Outlook, Excel, Word, PowerPoint.
* Basic Computer Proficiency.
* Knowledge in Relevant Scientific Field.
* Knowledge of Research Techniques or Methods.
* Knowledge of Regulatory Policies and Procedures.
* Analytical Skills.
* Outpatient clinical environment (primarily) and lab environment.
* Ability to travel to multiple clinical sites.
* Ability to stand for extended periods.
* Ability to use computer for extended periods.

When applying, the document(s)
** MUST
* * be uploaded via the
** My Experience
** page, in the section titled
** Application Documents
** of the application.

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