Miami University
Clinical Research Data Specialist
Miami, FL, USA · Staff+ · Part-time
Sponsorship not specifiedDetected 15 days ago
GCPHRISEHR/EMRClinical TrialsClinical ResearchPatient CareResearchGxP
About the role
- The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines.
Responsibilities
- Performs chart review/pre-screening activities for study participant eligibility and coordination of simple clinical research protocols. Maintains enrollment procedures according to the protocol.
- Manages a workload of studies commensurate to level of experience
- Develops source data worksheets specific to each assigned study.
- Maintains logs (i.e. Study Database, Velos etc.) in a timely manner according to department SOPs.
- Maintains study binders and filings according to protocol requirements and department policy.
- Maintains screening, enrollment, adverse event, deviation, concomitant medication, delegation and other sponsor and/or protocol specific logs.
Requirements
- 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.
- Ability to work independently and/or in a collaborative environment.
- Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
- High school diploma or equivalent. Some college level courses.
Benefits
- 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.
- Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
Visa & Work Authorization
- Maintains screening, enrollment, adverse event, deviation, concomitant medication, delegation and other sponsor and/or protocol specific logs
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This listing is sourced directly from Miami University's careers page and normalized into a canonical job model.