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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:

• 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 those to the PI for their determination of patient eligibility for protocol enrollment.

• Enters required protocol enrollment report to CRIS Office and JHS CTO according to established procedures.  Complete sand submits to the CRIS Office and/or JHS CTO Office protocol specific forms as required per UM and/or JHS policies.

• Assist in the completion of protocol specific documents.  Obtain relevant medical information from patient clinic charts/medical records.  Maintain logs/progress reports to track both currently enrolled as well as follow-up participants.  Provide protocol specific study documentation required in the management of study patient as per the protocol, federal regulations, and sponsor requirements and as required per UM policy.

• Under the supervision of the Principal Investigator.  Determine data to be collected and develop forms for collecting/summarizing data.  Enter data onto case report forms and/or into computer database as appropriate.  Complete corrections/queries required at audits/monitor visits.  Ensure data integrity and consistency in computer database and written records.

• Assist the Clinical Study Coordinator for the entry of and maintenance of the patient calendar.  Ensure protocol specific data is entered into Velos.

• Enters data onto case report forms and/or into computer database. Completes corrections/queries required at audits/monitor visits in a timely manner. Ensures data integrity and consistency in computer database and written records by reviewing entered data for accuracy.

• Query data inconsistencies and revise case report forms in compliance with standard operating procedures, Institutional, Federal and Regulatory guidelines.

• Actively participates in monitoring visits/site audits, etc.  Seek review and approval of the Principal Investigator.

• Assist the Clinical Study Coordinator to maintain screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.

• Ensures that randomization and registration of patients are performed in compliance with CRS and UM policies, the protocol, ICH-GCP, and federal regulations.

• Provides support with study related procedures as required, i.e., EKG, laboratory and tumor assessment studies.

• 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.

• Engage in continuing education of research policies/guidelines.  Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in field of expertise.

• Other duties as assigned.

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.

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