- Extracts clinical data and research data from electronic medical records and other sources and enters
- 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
- 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
- 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)
- 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
- Ensures work environment is organized and functions efficiently. Participates in a collaborative,
- Adheres to University and unit-level policies and procedures and safeguards University assets.
- 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
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Clinical Research Data Specialist - Miami, United States - The University of Miami
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.
CORE JOB FUNCTIONS
professional practice that supports the delivery of appropriate care and positive working relationships
throughout the medical center.
duties or responsibilities as necessary.
CORE QUALIFICATIONS
Education:
High school diploma or equivalent
Experience:
No experience required
Knowledge, Skills and Attitudes:
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.
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