Clinical Research Data Specialist (A)

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

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 assures 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

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 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

Department Specifics

• Assists the Monitors, Clinical research Coordinators and PIs in the organization and preparation of Site Initiation Visits (SIV).
• Attend site disease group tumor board meetings and site disease group collaborative meetings usually composed of PIs, sub-PIs, CRCs, IT, and Regulatory Staff.
• Assist the Clinical Research Coordinators ensuring that all protocol revisions, informed consents, continuing reviews, serious adverse events are submitted to the appropriate IRB of record in a timely manner.
• Assists PI in obtaining informed consent and documents the informed consent process as required.  Compiles patient data and presents tho