Clinical Research Data Specialist

University of Miami Miller School of Medicine•Miami, FL

42d•Onsite

About The Position

The Clinical Research Data Specialist 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. 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.

Requirements

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.

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 assure 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.