Clinical Research Data Specialist (A)

University of Miami; Miami, Northern (FL, KY); Hybrid; USD 52,000 - 75,000; Full time

Benefits offered by this job

Competitive salaries

Medical & dental benefits

Tuition remission

University-based health system

Job summary

The University of Miami Health System is seeking a Full-Time Clinical Research Data Specialist to support the SCCC program at the UHealth campus in Miami, FL. This role focuses on extracting and entering clinical and research data, maintaining study logs, and ensuring regulatory and SOP compliance under PI supervision.

Responsibilities include data queries, site initiation and monitoring coordination, and collaboration with multidisciplinary teams to prepare patient cases and ensure protocol

Qualifications

• High school diploma or equivalent.
• No experience required.
• Ability to analyze, organize and prioritize work under pressure while meeting deadlines.
• Ability to handle confidential information with discretion.
• Ability to work evenings, nights, and weekends as necessary.

Responsibilities

• Extracts clinical and research data from EMRs and enters into eCRF or paper-based systems.
• Manage workload across studies commensurate to experience.
• Respond to data clarifications for each study.
• Coordinate with monitors to ensure patient cases are ready for visits.
• Develop source data worksheets for assigned studies.
• Ensure regulatory compliance and SOP adherence across study activities.
• Maintain logs (e.g., TAS submissions, Velos) per SOPs.
• Assist in site initiation visits and team meetings as required.
• Maintain study binders and filings per protocol requirements.

Skills

Data extraction

Data entry

Regulatory knowledge

Attention to detail

Time management

Teamwork

Education

High school diploma

Tools

Velos

EDC

Job description

## Clinical Research Data Specialist (A)Applyremote type: On-Sitelocations: Miami, FLtime type: Full timeposted on: Posted Todayjob requisition id: R100098320**Current Employees:**If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.The University of Miami/UHealth Department of SCCC has an exciting opportunity for a Full-Time Clinical Research Data Specialist to work at the UHealth campus in Miami, Fl. CORE SUMMARYThe 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, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines.CORE JOB FUNCTIONS 1. Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study. 2. Manages a workload of studies commensurate to level of experience 3. Answers data clarifications (i.e. data queries) for each study. 4. Schedules and meets with study monitors and assure patient cases are ready for each monitor visit and items are addressed after each monitoring visit. 5. Develops source data worksheets specific to each assigned study. 6. Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. 7. Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. 8. Maintains logs (i.e. TAS submissions, Velos etc.) in a timely manner according to department SOPs. 9. Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required. 10. Assists multidisciplinary team in research activities. 11. Maintains study binders and filings according to protocol requirements and department policy. 12. Adheres to all UM and department policies and procedures. 13. Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment. 14. Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs. 15. Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center. 16. 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 equivalentExperience: no experience requiredKnowledge, Skills and Attitudes: • Skill in completing assignments accurately and with attention to detail. • Ability to analyze, organize and prioritize work under pressure while meeting deadlines. • Ability to process and handle confidential information with discretion. • Ability to work evenings, nights, and weekends as necessary. • Commitment to the University’s core values. • Ability to work independently and/or in a collaborative environment.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.