Clinical Research Data Specialist 2

Socket.dev; Miami (FL); On-site; USD 55,000 - 75,000; Full time

Job summary

University of Miami Health System is seeking a Clinical Research Data Specialist 2 in Miami to independently create, update, and maintain research charts and case report forms, with limited supervision from the PI and supervisor. You will compile, register, and submit data, monitor protocol compliance, and ensure regulatory alignment.

The role involves coordinating monitoring visits, maintaining study docs, and ensuring timely, accurate data entry and data integrity across multiple studies in a

Qualifications

• High School Diploma or equivalent or relevant experience with any required certification or license.
• Minimum 2 years of relevant experience in clinical data management or research data handling.
• Experience working with data capture systems and regulatory documentation is preferred.

Responsibilities

• Review and abstract medical records for research participants across studies.
• Enter clinical and research data into data capture systems with accuracy and timeliness.
• Ensure data quality, completeness, and protocol adherence.
• Respond to data clarifications and escalate complex issues when needed.
• Prepare materials for monitoring visits and address post-visit follow-up items.
• Maintain source documentation and study logs to support compliance and inspections.

Skills

Learning Agility

Teamwork

Technical Proficiency

Communication

Education

High School Diploma or equivalent/relevant experience, certification or license

Job description

CORE SUMMARY

The Clinical Research Data Specialist 2 independently creates, updates, and maintains research charts and case report forms, including regulatory‑related documentation, in accordance with department standard operating procedures, with limited supervision from the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist 2 is responsible for accurate and timely data compilation, registration, and submission, ongoing monitoring of protocol compliance, adherence to SOPs, and all applicable regulations and guidelines.

CORE JOB FUNCTIONS

• Reviews and independently abstracts medical records for research participants across multiple assigned studies with moderate complexity.
• Extracts, validates, and enters clinical and research data from electronic medical records and source documents into paper‑based or electronic data capture systems.
• Ensures data accuracy, completeness, and timeliness in accordance with protocol requirements and study timelines.
• Resolves and responds to data clarifications (i.e., data queries) independently, escalating complex issues as needed.
• Coordinates and supports routine monitoring visits by preparing participant cases, documentation, and source data, and by addressing post‑visit follow‑up items.
• Addresses and closes clinical and data discrepancies identified in monitoring reports prior to subsequent monitoring visits.
• Develops and maintains study‑specific source documentation and worksheets aligned with protocol and sponsor requirements.
• Maintains proactive communication with information services, providers, and research staff to support ongoing data collection and issue resolution.
• Documents and tracks study‑specific activities, including monitoring visits, enrollments, protocol amendments, and safety reports, within the clinical trial management system in real time.
• Ensures all study documentation meets internal, external, sponsor, and regulatory requirements in accordance with protocol guidelines.
• Maintains and audits study‑related logs and tracking tools to support compliance and inspection readiness.
• Participates in site initiation visits, monitoring visits, and PI oversight or study team meetings, contributing data‑related insight as appropriate.
• Supports and collaborates with multidisciplinary research teams to facilitate study execution and data integrity.
• Maintains organized, audit‑ready study binders and regulatory files and contributes to an efficient, compliant, and collaborative research environment.
• Adheres to University and unit-level policies and procedures and safeguards University assets.

This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.

CORE QUALIFICATIONS

Education: High School Diploma or equivalent/relevant experience, certification or license

Experience: Minimum 2 years of relevant experience required

Knowledge, Skills and Abilities

• 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.

The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.

UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.

The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.

Job Status

Full time

Employee Type

Staff