Clinical Research Data Specialist

Summary

The University of Miami is an academic medical center providing leading-edge patient care and medical education. They are seeking a Clinical Research Data Specialist to assist in maintaining research charts and case report forms while ensuring compliance with regulatory guidelines and protocols.

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

Skills

• 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

Qualifications

Must Haves

• 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

• Competitive salaries
• A comprehensive benefits package including medical, dental, tuition remission and more