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 and under the supervision of the Principal Investigator and supervisor. The specialist compiles, registers, and submits data; monitors compliance with protocols; and supports adherence to SOPs and applicable regulations and guidelines. The position is full-time with the University of Miami Department of SCCC at the UHealth medical campus in Miami, Florida.

Requirements

High school diploma or equivalent; relevant experience, certification, or license may be considered.
No previous experience required.
Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
Ability to work collaboratively 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 paper-based or electronic data capture systems for assigned studies.
Manage a workload of studies commensurate with experience.
Answer data clarifications and queries for each study.
Schedule and meet with study monitors, ensure patient cases are ready for monitoring visits, and address follow-up items.
Develop source data worksheets for assigned studies.
Address and close clinical issues from monitoring reports before the next monitoring visit.
Ensure study requirements are documented and meet internal and external regulations and protocol guidelines.
Maintain logs, including TAS submissions and Velos, in a timely manner according to department SOPs.
Participate in site initiation and monitoring visits, site disease group team meetings, and PI oversight meetings as required.
Assist the multidisciplinary team with research activities.
Maintain study binders and filings according to protocol requirements and department policy.
Adhere to University and department policies and procedures.
Compile patient data for Investigator review to determine 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.
Safeguard University assets and follow University and unit-level policies and procedures.
Perform other duties or responsibilities as necessary.