Clinical Study 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.

The Clinical Study Associate will be responsible for supporting the study  management of observational/non-interventional 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 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 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 

Demonstration of Tempus Compass Values: 

Consistently strives to demonstrate the following Tempus Compass values: 

• Recognizes that the team is always stronger than the individual 
• Seeks to inspire others by demonstrating consistently strong performance 
• Treats people with respect regardless of role or point of view 
• Listens well and seek to understand before reacting 
• Provides candid, helpful and timely feedback to colleagues 
• Demonstrates curiosity about and contributes effectively to areas outside of their specialty
• Keeps the bigger picture in mind when making decisions 
• Never stops learning 
• Questions assumptions and offers suggestions for improvement 
• Focuses on results rather than process and seeks to minimize complexity when process is required
• Identifies and addresses root causes, not symptoms 
• Demonstrates poise in stressful situations 
• Strives to always do the right thing
• Questions actions that are incongruent with Tempus Compass values 

Minimum Qualifications 

• 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) 

Preferred Qualifications 

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

 

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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.