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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.
Department Specific Functions
The Clinical Research Data Specialist will participate in the research activities of the Division of Pulmonary, Critical Care and Sleep Medicine at the Miller School of Medicine within the Department of Medicine. The individual will work closely with the Principal Investigator (PI) focusing on 2019 Novel Coronavirus (COVID-19) studies. This includes sample collection, analysis of data sets, lab collaboration and production of academic journal articles. Due to COVID-19 this employee should expect a work week with fluctuating hours as needed by the Principal Investigator.
CORE JOB FUNCTIONS
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. Manages a workload of studies commensurate to level of experience Answers data clarifications (i.e. data queries) for each study. Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit. Develops source data worksheets specific to each assigned study. Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Maintains logs (i.e. TAS submissions, Velos etc.) in a timely manner according to department SOPs. Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required. Assists multidisciplinary team in research activities. Maintains study binders and filings according to protocol requirements and department policy. Adheres to all UM and department policies and procedures. Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment. Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs. Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center. Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
High school diploma or equivalent required
No experience required. Any appropriate combination of relevant education, experience and/or certifications may be considered.
Knowledge, Skills and Attitudes:
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