Description/Comment: 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:
• 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
The essential requirements of the job include:
• 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
It would be a plus if you also possess previous experience in:
• 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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