Clinical Research Data Specialist 2

University of Miami; Miami (FL); Hybrid; USD 60,000 - 85,000; Full time

Benefits offered by this job

Comprehensive benefits

Tuition remission

Medical coverage

Job summary

The University of Miami/UHealth Department of SCCC is seeking a Full-Time Clinical Research Data Specialist 2 at the UHealth campus in Miami, FL. The role focuses on creating and maintaining research charts and case report forms with supervision from the PI and supervisor, ensuring timely data submission and protocol compliance.

Responsibilities include data extraction from EMRs, data validation, monitoring visits preparation, and collaboration with multidisciplinary teams to resolve data

Qualifications

• Learning agility: ability to learn new procedures, technologies, and protocols.
• 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

• Reviews and independently abstracts medical records for research participants across studies with moderate complexity.
• Extracts, validates, and enters clinical data from EMRs and source documents into data capture systems.
• Ensures data accuracy, completeness, and timeliness per protocol and study timelines.
• Responds to data clarifications and escalates complex issues as needed.
• Coordinates and supports routine monitoring visits with documentation and follow-up.

Skills

Learning Agility

Teamwork

Technical Proficiency

Communication

Education

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

Job description

The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Clinical Research Data Specialist 2 to work at the UHealth campus in Miami, Fl.

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

• 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

The mission of the University of Miami is to transform lives through education, research, innovation, and service. A vibrant and diverse academic and healthcare community, the University of Miami and the University of Miami Health System ("UHealth") have rapidly progressed to become one of the nation’s top research universities and academic medical centers in the nation. The University comprises 12 schools and colleges serving undergraduate and graduate students in more than 350 majors and programs. Visit welcome.miami.edu/about-um to learn more about our points of pride. The University ranks No. 55 on U.S. News & World Report’s 2022 Best Colleges list and ranked No. 49 in the 2022 Wall Street Journal/Times Higher Education College Rankings. Bascom Palmer Eye Institute is ranked the #1 eye hospital in the USA and offers some of the nation's premiere eye doctors to treat every eye condition for adults. Sylvester Comprehensive Cancer, part of the Miller School of Medicine, received the prestigious National Cancer Institute designation in 2019. The University of Miami and UHealth have also ranked among the Forbes Best Employers and Best Employers for Women on several occasions, most recently in 2022. With more than 17,000 faculty and staff, the University strives for excellence, and is driven by a powerful mission to transform and impact the lives of its students, patients, members of the community, and people across the globe.

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