Clinical Research Data Specialist

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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 Hybrid 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

• 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.

• Manages a workload of studies commensurate to level of experience

• Answers data clarifications (i.e., data queries) for each study.

• Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.

• Develops source data worksheets specific to each assigned study.

• Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.

• Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.

• Maintains logs (i.e., TAS submissions, Velos etc.) in a timely manner according to department SOPs.

• Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.

• Assists multidisciplinary team in research activities.

• Maintains study binders and filings according to protocol requirements and department policy.

• Adheres to all UM and department policies and procedures.

• Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.

• Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.

• 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.

• 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 Abilities:
• 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:

Primary Duties and Responsibilities (For Non-exempt Employees Include Percent of Effort):

• Assist CTCU Clinical Research Coordinator team in study data entry.

• Research source documents to extract data for entry.

• Perform data quality checks.

• Assure all study data is entered to Velos to meet both internal and external regulations in accordance with protocol guidelines.

• Respond to data entry and report requests in a timely fashion.