About Prenosis

Prenosis Inc. is an artificial intelligence company pioneering precision medicine in acute care. Our Immunix™ precision medicine platform drives the development of precision products and enables real-time delivery of optimal therapy. We've created and validated the first FDA-authorized AI biomarker for sepsis, the Sepsis ImmunoScore™.

At Prenosis, we:

• Put patients first
• Disrupt with evidence
• Excel with integrity
• Go far together

Our staff collectively defined these corporate values to demonstrate how our teams contribute to meaningful and authentic change in U.S. healthcare. We value our diverse talent, strive to foster a culture of continuous learning, and aim to maintain a feeling of belonging and shared sense of purpose.

Prenosis is headquartered in Chicago Illinois and generally operates on Central Time Zone.

Position Summary

Prenosis is seeking a highly organized and detail-oriented Clinical Research Associate (CRA) to support the execution, monitoring, management and coordination of our sponsored observational and interventional clinical studies conducted at multiple institutions in the United States. This position will play a vital role in ensuring adherence to study protocols and regulatory requirements while maintaining strong, proactive communication with site research staff and/or Contract Research Organization (CRO)/Academic Research Organization (ARO) personnel. The candidate should be an independent problem solver with strong communication skills, and capable of overseeing study operations with minimal supervision.

Responsibilities

General

• Conduct on-site and remote visits, monitoring and assessment of clinical trial sites, ensuring adherence to study protocols, Good Clinical Practice (GCP) guidelines, and applicable regulatory requirements.
• Perform source document verification (as applicable), data collection, and accurate recording of study data, ensuring data integrity and compliance.
• Monitor subject safety, reporting adverse events, and ensuring appropriate follow-up actions are taken, as applicable.
• Contribute to the preparation and coordination of study initiation, monitoring, and close-out activities.
• Assist in the preparation and participation in regulatory inspections and audits as necessary.

Site Communication and Support

• Maintain proactive communication with clinical research staff at participating sites to support study execution
• Promptly address site-related issues and escalate to appropriate Prenosis personnel as needed.

Study Documentation Management

• Manage and maintain all essential regulatory and trial documents across all study phases: site qualification, study approval, site initiation, interim monitoring, and closeout.
• Track and ensure compliance with required documentation timelines (e.g., training logs, IRB approvals, protocol updates, adverse event reporting (as applicable)

Protocol and IRB Coordination

• Assist in coordinating submissions with central IRB.
• Monitor and document any changes in study personnel, IRB approvals, or protocol deviations.

Training and Oversight

• Complete training of research staff on study-related procedures, workflows, and documentation practices.
• Oversee site readiness and support the implementation of new processes or updates throughout the study.
• Monitor training of new research staff throughout the duration of the study/trial.

Performance Tracking and Reporting

• Monitor site-level patient recruitment and sample collection rates in accordance with enrollment goals, as applicable.
• Regularly report study status and site performance metrics to internal company leadership.

Biospecimen and Data Workflow Oversight

• Continuously monitor patient recruitment and sample collection rates and performance in accordance with Clinical Research processes and SOPs.
• Identify issues and collaborate with external and internal stakeholders to find solutions

Other duties may be assigned based on trial/study needs.

Expected frequency and duration of travel: Approximately 10-20%

Qualifications and Experience

Required:

• Bachelor’s degree or equivalent combination of education, training, and experience.
• 3+ years of experience in clinical research or clinical trial coordination.
• Experience in interventional and/or observational trials/studies
• Exceptional organizational skills, attention to detail and ability to manage multiple priorities
• Excellent interpersonal and communication skills; able to work collaboratively with site staff and internal teams.
• Comfortable working independently while collaborating in a cross-functional environment.
• Strong understanding of applicable clinical research regulatory requirements, (i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines, and FDA regulations) and clinical trial operations.

Preferred:

• Experience with EHR systems (e.g. EPIC, Cerner), CTMS, eTMF and eISF platforms and data capture systems
• Problem-solving mindset; ability to navigate fast-paced environments
• Experience with biomarker studies and/or acute care clinical research
• Experience with AI-enable platforms and/or Software as a Medical Device studies (SaMD)
• Proficiency with Microsoft Office Suite and clinical trial management tools

What We Offer

• Comprehensive Medical, dental, and vision coverage
• 401(k) with company match
• Unlimited time off
• Major opportunity for career development to make significant impact at an exciting growth-stage company
• Collaborative and innovative work environment
• Chance to make a real impact on patient care
• Opportunity to work on cutting-edge AI technology in healthcare

Salary Range: $65,000 - $85,000 per year

Prenosis is an Equal Opportunity Employer

Must be eligible to work in the US without sponsorship