Location: Hyde Park Campus Job Description: Manages the daily administrative and technical activities in a single highly complex, large clinical trial or multiple moderately complex, concurrent clinical trials. Designs and guides internal and external audits and manages external surveys. Implements Good Clinical Practices (GCP) and all relevant current local, state, and federal laws, regulations, policies and procedures. Develops and implements consistent standards and protocols. Solves complex problems relating to data management and the analysis of large administrative datasets. Works independently to develop, manage, and report on key data and ensures timeliness of data and reporting submissions from multiple investigators. Acts as a resource on the basics of clinical research and related aspects of clinical study for colleagues with less experience. Prepares and evaluates writing protocols, IRB submissions, grant applications, manuscripts, reports, and dissemination tools. Performs other related work as needed.
Preferred Qualifications Education: Experience: Preferred Competencies Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others. Ability to work collaboratively with a diverse range of individuals. Excellent time management skills and the ability to work independently. Strong organizational and communication (verbal and written) skills. Excellent interpersonal skills. Strong analytical skills. Ability to handle competing demands with diplomacy and enthusiasm. Strong data management skills and attention to detail. Competences in using Microsoft Word, Excel, PowerPoint, Adobe Acrobat, EPIC, REDCAP. Knowledge of regulatory policies and procedures. Ability to read and understand complex documents (e.g., clinical trials). Familiarity with medical and scientific terminology, IRB, study participant recruitment, and patient consent. Demonstrated knowledge of Good Clinical Practices (GCP). Adaptability to changing working situations and work assignments.
Working Conditions Application Documents Resume (required) Cover Letter (preferred)
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