Clinical Research Data Specialist 2

CORE JOB 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

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

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 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. #J-18808-Ljbffr University of Miami