University of Miami · 3 weeks ago
Clinical Research Data Specialist
Miami, FL
Full-time
Onsite
New Grad, Entry Level
0+ years expThe University of Miami is an academic medical center providing leading-edge patient care and research. They are seeking a Clinical Research Data Specialist to assist in creating and maintaining research charts, ensuring compliance with protocols, and managing data for clinical studies.
Higher Education
Responsibilities
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
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
Qualification
Required
High school diploma or equivalent
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
Medical
Dental
Tuition remission
And more
Company
University of Miami
At UM you'll join a diverse and energized academic community.
5001-10000 employees
H1B Sponsorship
University of Miami has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (208)
2024 (151)
2023 (149)
2022 (121)
2021 (95)
2020 (114)
Funding
Current Stage
Late StageLeadership Team
Albertie Regalado
'Canes Science Bowl — Co-Founder and Co-President
Mark McPheron, FALU, CLU, FLMI
Co-Founder and Past President, and current member, University of Miami Cincinnati 'Canes Community
Recent News
Seattle TechFlash
2023-11-22
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