Clinical Research Data Specialist

Full-Time Clinical Research Data Specialist – UHealth campus, Miami, FL Core Job Functions Extract clinical and research data from electronic medical records and other sources and enter into paper‑based or electronic data capture systems for each assigned study. Manage a workload of studies commensurate with level of experience. Answer data clarifications (queries) for each study. Schedule and meet with study monitors; ensure patient cases are ready for each monitor visit and follow up on monitoring items. Develop source data worksheets specific to each assigned study. Ensure clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. Document all study requirements and confirm compliance with internal and external regulations and protocol guidelines. Maintain logs (e.g., TAS submissions, Velos) timely according to SOPs. Participate in site initiation visits, monitoring visits, and disease group meetings as required. Assist multidisciplinary team in research activities. Maintain study binders and filings according to protocol requirements and department policy. Adhere to UM and department policies and procedures and safeguard University assets. Compile patient data for investigator review to determine patient eligibility for protocol enrollment. Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation, and other sponsor or protocol‑specific logs. Ensure work environment is organized and functions efficiently; participate in a collaborative, empowered work environment. Adhere to University and unit‑level policies and procedures and safeguard University assets. Core Qualifications Education: High school diploma or equivalent. Experience: No experience required. Knowledge, Skills and Attitudes: 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. The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more. The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. #J-18808-Ljbffr SwiftCruit