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University of Miami · 12 hours ago

Clinical Research Data Specialist

Miami, FL

Full-time

Onsite

New Grad, Entry Level

0+ years exp

The University of Miami is a leading academic medical center providing cutting-edge patient care and research. They are seeking a Clinical Research Data Specialist to assist in maintaining research charts, compiling data, and ensuring compliance with protocols and regulations. The role involves managing clinical data, participating in monitoring visits, and collaborating with a multidisciplinary team.

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

Clinical data extractionElectronic data captureRegulatory complianceLearning agilityTechnical proficiencyTeamworkCommunication

Required

High School Diploma or equivalent/relevant experience, certification or license

No Previous Experience Required

Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands

Teamwork: Ability to work collaboratively with others and contribute to a team environment

Technical Proficiency: Skilled in using office software, technology, and relevant computer applications

Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders

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)