Clinical Research Data Specialist

Responsibilities 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 ensures 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, participating in a collaborative, empowered work environment. 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. Core Qualifications Education: High school diploma or equivalent. Experience: No experience required. Skill in completing assignments accurately and with attention to detail. Ability to analyze, organize and prioritize work under pressure while meeting deadlines. Ability to process and handle confidential information with discretion. Ability to work evenings, nights, and weekends as necessary. Commitment to the University’s core values. Ability to work independently and/or in a collaborative environment. Benefits The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. #J-18808-Ljbffr University of Miami