Remote Clinical Study Associate

Summary

The Clinical Study Associate will support the management of observational/non-interventional studies at Tempus to ensure GxP quality principles are implemented. Key responsibilities include executing studies in compliance with quality standards, leading cross functional study teams, developing and publishing study materials, and proactively resolving study related issues.

Requirements

• Bachelor’s Degree, typically in nursing or scientific field; Registered Nurse licensure with Associate’s Degree in Nursing with relevant experience is also acceptable
• 1+ years of Pharma-related or clinical research related experience or professional equivalent desired
• Competent in application of standard business procedures (SOPs, GCP, GDP)
• Excellent organizational skills with high attention to detail
• Ability to independently perform multiple tasks at the same time
• Strong communication skills (oral and written)

Responsibilities

• Responsible for supporting the execution of Tempus’ observational or non interventional studies in compliance with quality standards (ICH/GCP, Global Regulations, and Tempus policies and procedures)
• Supports the Clinical Study Manager in leading the cross functional study teams
• Supports the preparation and documentation of Study Team meetings (Agenda/Minutes)
• Supports the development and publications of study materials including study protocol, Informed Consent Form, and other site documents
• Supports the oversight of clinical study external vendors
• Proactively identifies and resolves and/or escalates study related issues
• Applies critical thinking to ensure real-time inspection readiness by: Investigating and proactively resolving issues, Communicates to Clinical Study Manager root cause analysis and potential data integrity concerns

Preferred Qualifications

• Familiarity with the molecular biology of cancer including genomics, proteomics, and immunology
• Experience working in electronic systems (eTMF, CTMS, EDC, etc.)