Job Description

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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 medical campus in Miami, FL.

CORE JOB SUMMARY
The Clinical Research Data Specialist assist s in creating, updating, and maintaining research charts and case report forms, including regulatory rela ted issues, in accordance with department standard operating p rocedures , under the
supervisio n 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 a nd 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 assures patient cases are ready for each monitor visit and items
are addressed af ter each monitoring visit.
5. Develop s 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. Assure s all study requirements are documented and mee t both internal and external regulations in accordance
with protocol guidelines.
8. Maintain s logs (i.e. TAS submissions, Velos etc.) in a timely manner according to department SOPs.
9. P articipate s in site initiation visits (SIV), monitoring visits and particip ate s in site disease g roup (SDG) team and
PI oversight meetings as required.
10. Assist s multidisciplinary team in research activities.
11. Maintain s study binders and filing s according to protocol requirements and department policy.
12. Adhere s to all UM and department policies and procedures.
13. Compile s patient data for Investigator review to determine patient eligibility for protocol enrollment.
14. Maintain s screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication,
delegation an d other sponsor and/or protocol specific logs.
15. Ensure s work environment is organized and functions efficiently. Participate s in a collaborative, empowered work
environment as demonstrated through teamwork. Demonstrates a level of professional practice th at 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

Experience:
No experience required

Knowledge, 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 confid ential information with discretion.
• Ability to work evenings, nights, and weekends as necessary.
• Commitment to the University’s core values.

#LI-YC1

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 - Females/Minorities/Protected Veterans/Individuals with Disabilities are encouraged to apply. Applicants and employees are protected from discrimination based on certain categories protected by Federal law. Click here for additional information.

Job Status:

Full time

Employee Type:

Staff

Pay Grade:

A6

Job Tags

Full time, Temporary work, Worldwide, Night shift, Weekend work, Afternoon shift,

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