ClinicalResearchDataSpecialist

**_Current Employees:_** If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click [here](https://www.myworkday.com/umiami/d/task/1422$7248.htmld) to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this [tip sheet](https://my.it.miami.edu/wda/erpsec/tipsheets/ER_eRecruiting_ApplyforaJob.pdf). The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Clinical Research Data Specialist to work at the UHealth campus in Miami, Fl. **CORE JOB SUMMARY** The Clinical Research Data Specialist assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines. **CORE JOB FUNCTIONS** 1\. Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study. 2\. Manages a workload of studies commensurate to level of experience 3\. Answers data clarifications (i.e., data queries) for each study. 4\. Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit. 5\. Develops source data worksheets specific to each assigned study. 6\. Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. 7\. Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. 8\. Maintains logs (i.e., TAS submi