Clinical Research Data Specialist 2

University of Miami•Miami, FL

8d•Onsite

About The Position

The Clinical Research Data Specialist 2 independently creates, updates, and maintains research charts and case report forms, including regulatory-related documentation, according to department standard operating procedures, with limited supervision from the Principal Investigator and supervisor. The role is responsible for accurate and timely data compilation, registration, and submission; ongoing monitoring of protocol compliance; adherence to SOPs; and compliance with applicable regulations and guidelines. The specialist supports multiple moderately complex studies by abstracting medical records, extracting and validating clinical and research data, managing data queries and discrepancies, and preparing for monitoring visits. The position also maintains study-specific documentation, logs, tracking tools, clinical trial management system records, study binders, and regulatory files to support study execution, data integrity, compliance, and inspection readiness. The role collaborates with multidisciplinary research teams and communicates with information services, providers, and research staff.

Requirements

High school diploma or equivalent, or relevant experience, certification, or license.
Minimum 2 years of relevant experience.
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 using office software, technology, and relevant computer applications.
Strong written and verbal communication skills for interacting with colleagues and stakeholders.

Responsibilities

Review and independently abstract medical records for research participants across multiple assigned studies of moderate complexity.
Extract, validate, and enter clinical and research data from electronic medical records and source documents into paper-based or electronic data capture systems.
Ensure data accuracy, completeness, and timeliness in accordance with protocol requirements and study timelines.
Independently resolve and respond to data clarifications and queries, escalating complex issues as needed.
Coordinate and support routine monitoring visits by preparing participant cases, documentation, and source data, and addressing post-visit follow-up items.
Address and close clinical and data discrepancies identified in monitoring reports before subsequent monitoring visits.
Develop and maintain study-specific source documentation and worksheets aligned with protocol and sponsor requirements.
Communicate proactively with information services, providers, and research staff to support ongoing data collection and issue resolution.
Document and track study-specific activities, including monitoring visits, enrollments, protocol amendments, and safety reports, in the clinical trial management system in real time.
Ensure study documentation meets internal, external, sponsor, and regulatory requirements in accordance with protocol guidelines.
Maintain and audit study-related logs and tracking tools to support compliance and inspection readiness.
Participate in site initiation visits, monitoring visits, PI oversight, and study team meetings, contributing data-related insight as appropriate.
Collaborate with multidisciplinary research teams to facilitate study execution and data integrity.
Maintain organized, audit-ready study binders and regulatory files and contribute to an efficient, compliant, and collaborative research environment.
Adhere to University and unit-level policies and procedures and safeguard University assets.
Perform other duties or responsibilities as necessary.