Clinical Study Operations Associate
Passionate about precision medicine and advancing the healthcare industry?
Tempus' proprietary platform connects an entire ecosystem of real-world evidence to deliver real-time, actionable insights to physicians, providing critical information about the right treatments for the right patients, at the right time.
We're looking for a Clinical Study Operations Associate to help us execute clinical studies with the mission of delivering personalized care to patients. The Clinical Study Operations Associate will be responsible for supporting the study management of Tempus Sponsored Clinical Studies to ensure GxP quality principles are implemented from study startup through database lock activities.
Key Responsibilities Include:
- Responsible for supporting the execution of Tempus’ observational or 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
- Supports clinical study site selection and qualification activities
- Proactively identify and resolve and/or escalate 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
- Supports Clinical Study Manager in leading the cross functional study teams
- Complies with GCP, Tempus SOPs and functional area processes, procedures and regulations
- 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)
- Familiarity with the molecular biology of cancer including genomics, proteomics, and immunology
- Experience working in electronic systems (eTMF, CTMS, EDC, etc.)
We are an equal opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
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