Clinical Research Data Specialist - Division of Infectious Diseases
University of Miami

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The University of Miami/UHealth Department of Medicine, Infectious Diseases Division has an exciting opportunity for a full time Clinical Research Data Specialist to work in the UHealth Medical Campus.

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 (Pl) 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 Responsibilities

• 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
• 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.
• 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.

Department Specific Functions

• Responsible for study recruitment, screening, schedule participants and assessments activities of different research projects.
• Work closely with the Research Data Manager in maintaining and updating study records and databases and respond data queries in a timely manner.
• Work in conjunction with the Research Data Manager in conduct quality control checks on clinical research data.
• Work in conjunction with the Research Data Manager in the development of data collection instruments for study protocols and other research documents and operations.
• Work in conjunction with the Research Data Manager in generating reports and present data to investigators for continuing reviews or other progress reports as needed.
• Responsible in maintain appropriate logs, records, and study notebooks.
• Responsible to record procedures and results in participant binders and databases per study protocols.
• Responsible to ensure the accuracy, completeness, and consistency of clinical research data.
• Reviews and edits various materials for publication and prepares publication schedules.
• Adheres to University and unit-level policies and procedures and safeguards University assets.
• Work in conjunction with the Research Data Manager to perform basic descriptive analysis of clinical research data where appropriate.

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

Any relevant education, certifications and/or work experience may be considered.

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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 timeEmployee Type:StaffPay Grade:A6

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