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University of Miami · 8 hours ago

Clinical Research Data Specialist

Plantation, FL

Full-time

Onsite

New Grad, Entry Level

0+ years exp

The University of Miami is an academic medical center that provides leading-edge patient care and is seeking a Clinical Research Data Specialist. This role involves assisting in the creation, updating, and maintenance of research charts and case report forms while ensuring compliance with protocols and regulations.

Higher Education

H1B Sponsor Likely

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 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

AnalyzeAttention to detailOrganizational skillsConfidential information handlingTeamwork

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

Benefits

Medical

Dental

Tuition remission

And more

Company

University of Miami

Glassdoor3.9

At UM you'll join a diverse and energized academic community.

Founded in 1925

Coral Gables, fl, US

5001-10000 employees

http://miami.edu

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 (137)

2024 (153)

2023 (150)

2022 (122)

2021 (95)

2020 (114)