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    Clinical Research Data Specialist - Doral, United States - University of Miami

    University of Miami
    University of Miami Doral, United States

    4 weeks ago

    Default job background
    Description

    Current Employees:


    If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process.

    To learn how to apply for a faculty or staff position using the Career worklet, please review this tip sheet.

    The SCCC CRS department is seeking a Clinical Research Data Specialist the CRDS 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.

    The CRDS enters alphabetic, numeric or symbolic data from source documents into computer, using a data entry device, such as keyboard or optical scanner.

    Performs data entry which may include researching, verifying, coding, and correcting information to be entered into a database. Keys data into the proper program to control format and fields. Verifies entries for accuracy and completeness. Sorts and files correspondence, reports, and other relevant materials. Processes documents requiring various procedural knowledge specific to area of assignment. Obtains necessary signatures and routes appropriately. Maintains data confidential, at all times. Adheres to University and unit-level policies and procedures and safeguards University assets.

    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 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
    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.
    Patient safety is a top priority.

    As a result, during the Influenza ("the flu") season (September through April), the University Of Miami Miller School Of Medicine requires all employees who provide ongoing services to patients, work in a location (all Hospitals and clinics) where patient care is provided, or work in patient care or clinical care areas, to have an annual influenza vaccination.

    Failure to meet this requirement will result in rescinding or termination of employment.
    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

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