Clinical Research Data Specialist

University of Miami; Miami (FL); On-site; USD 50,000 - 70,000; Full time

Job summary

University of Miami is seeking a Clinical Research Data Specialist for our UHealth campus in Miami, FL. The role supports data capture, monitoring visits, and regulatory compliance under the PI and supervisor. Experience is not required, but strong learning agility is essential.

The position is full-time, on-site, with a patient-focused environment and collaboration across the research team. Competitive benefits apply.

Qualifications

• Education as stated: High School Diploma or equivalent/relevant experience.
• Ability to learn new procedures, technologies, and protocols.
• Proficient in standard office software.

Responsibilities

• Extracts data from EMRs or other sources and enters into data capture systems.
• Responds to data queries and supports monitoring visits.
• Maintains study logs and documentation per SOPs.
• Assists in site initiation visits and team meetings.

Skills

Learning agility

Teamwork

Technical proficiency

Written and verbal communication

Education

High school diploma or equivalent

Tools

Velos

Job description

## Clinical Research Data SpecialistApply: On-Site: Miami, FL: Full time: Posted Today: R100099571**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 at the UHealth medical campus in Miami, Florida. **CORE JOB SUMMARY** The 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 equivalent/relevant experience, certification or license Experience: No previous 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