- Support development of study essential document templates (e.g., study guides, study tools/worksheets) and ensure Trial Master File (TMF), Sponsor Site Files (SSF), and Investigator Site Files (ISF) are maintained and kept up to date; assist in audit readiness and preparation.
- Support clinical activities to stay in compliance with the study Monitoring Plan requirements and compliance to Protocol, applicable regulatory standards, IRB policies and procedures.
- Onsite and/or remote monitoring of data and overseeing corrective actions.
- Drive schedule deliverables to meet the overall study timelines
- Develop and drive centralized processes to optimize instrument device data, reconciliation of instrument data to sample list, identification of protocol deviations and data discrepancies to drive compliance to study protocol(s), applicable regulations, Good Clinical Practices (GCP) and Standard Operating Procedures.
- Partner with data management team to effectively operate within data management plan and data management procedures including the Laboratory Information Data Management System (LIDMS)
- Support clinical team which may include activities related to budget management, processing site compensation, supporting accruals, contract execution, collection and document retention of essential documentation, vendor support activities
- Adherence of PHI protection and GCP
- Bachelor's degree or equivalent in the life sciences, with 4+ years' work experience in vitro diagnostics (IVD), Medical Device, or Pharmaceutical research; 2+ years' experience with Master's degree, or 1+ years with Doctoral degree.
- Demonstrated agility with processes and details, ability to apply critically-thinking, analyze data (using analytical tools), and solve complex problems.
- Ability to work independently and effectively under a fast-paced and changing environment
- Proficiency Microsoft Office Excel and Outlook
- Able to travel 10% or as needed
- Real-world data
- Cardiovascular clinical trials
- Electronic data capture (EDC) system (Medidata) and eTMF system (Florence)
- Clinical research certification (i.e., SOCRA, CCRA, CCRC)
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Research Associate
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Florida International University Miami, United StatesThe Center for Translational Science at FIU located in Port St. Lucie, Florida is currently recruiting 2 Research Associate positions to study neurodegenerative diseases using genetically engineered rats as relevant models for motoneuron disease, fro Research Associate, Neuro, As ...
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YipitData Miami, United StatesAbout Us: · YipitData is the leading market research and analytics firm for the disruptive economy and recently raised up to $475M from The Carlyle Group at a valuation over $1B. · We analyze billions of alternative data points every day to provide accurate, detailed insights o ...
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Research Associate 1
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The University of Miami Miami, United StatesCurrent 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 ...
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Research Associate 1
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The University of Miami Miami, United StatesCurrent 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 ...
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Research Associate 1
31 minutes ago
The University of Miami Miami, United StatesCurrent 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 ...
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Research Associate 3
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The University of Miami Miami, United StatesCurrent 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 ...
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Research Associate 2, SOM
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Sr. Research Associate 1
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The University of Miami Miami, United StatesCurrent 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 ...
Clinical Research Associate IV - Miami, United States - Omni Inclusive
Description
The Clinical Research Associate (CRA) for Beckman Coulter Diagnostics is responsible for supporting clinical activities to generate clinical evidence that will support product registration and/or product market clearance/approval.
This position is part of the Clinical Affairs Department for the Clinical Decision Support business unit and is fully remote.
You will report to the Director of Clinical Affairs. You will be part of a cohesive, high-performing team who supports each other and have an attitude to win-as-one
The position provides an opportunity to combine your expertise in clinical research and integrate Danaher standard work processes to drive continuous process improvement and develop professionally.
Along with professional experience in a medical or research setting, we are looking for someone who is process-oriented, with strong communication, interpersonal, and project coordination skills.
If this describes you - read on.In this role, you will have the opportunity to: