Clinical Research Data Specialist

University of Miami•Miami, FL

1d•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. The role works under the supervision of the Principal Investigator (PI) and supervisor and is responsible for compiling, registering, and submitting data; monitoring protocol compliance; and adhering to SOPs and applicable regulations and guidelines. The position supports clinical research studies by extracting data from electronic medical records and other sources, entering data into paper-based or electronic systems, responding to data queries, preparing for monitor visits, maintaining study documentation and logs, and assisting multidisciplinary research teams. It also compiles patient data for investigator review to determine eligibility for protocol enrollment.

Requirements

High school diploma or equivalent, or relevant experience, certification, or license.
No previous experience required.
Ability to learn new procedures, technologies, and protocols and adapt to changing priorities and work demands.
Ability to work collaboratively with others and contribute to a team environment.
Proficiency with office software, technology, and relevant computer applications.
Strong written and verbal communication skills for interacting with colleagues and stakeholders.

Responsibilities

Extract clinical and research data from electronic medical records and other sources and enter it into the clinical paper-based or electronic data capture system for each assigned study.
Manage a workload of studies commensurate with level of experience.
Answer data clarifications and queries for each study.
Schedule and meet with study monitors, ensure patient cases are ready for monitor visits, and address items after each visit.
Develop source data worksheets specific to each assigned study.
Ensure clinical issues in monitoring reports are addressed and closed out before the next monitoring visit.
Ensure study requirements are documented and meet internal and external regulations in accordance with protocol guidelines.
Maintain logs, including TAS submissions and Velos, in a timely manner according to department SOPs.
Participate in site initiation visits, monitoring visits, site disease group team meetings, and PI oversight meetings as required.
Assist the multidisciplinary team in research activities.
Maintain study binders and filings according to protocol requirements and department policy.
Adhere to University, department, and unit-level policies and procedures and safeguard University assets.
Compile patient data for Investigator review to determine patient eligibility for protocol enrollment.
Maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation, and other sponsor- or protocol-specific logs.
Keep the work environment organized and efficient, contribute to a collaborative team environment, and support appropriate care and positive working relationships throughout the medical center.