Clinical Research Associate

Summary

Join Foresight Diagnostics, a molecular diagnostics company developing non-invasive cancer detection technologies, as a Clinical Research Associate. This role supports clinical trials, including data monitoring, TMF maintenance, and sample logistics management. You will collaborate with various teams and external stakeholders. Responsibilities include planning and conducting clinical trials, ensuring compliance with regulations, facilitating startup activities, performing monitoring tasks, managing biobanking, coordinating sample shipments, and improving laboratory processes. The position requires a Bachelor's or Master's degree, 5+ years of experience in clinical operations, and GCP/Human Subjects Research certification. Travel to Boulder, CO is required at least quarterly.

Requirements

• Bachelor’s or Master’s degree in relevant field
• 5+ years’ experience in Clinical Operations, including monitoring and TMF management
• Certification in Good Clinical Practice and Human Subjects Research
• Excellent written and verbal communication skills
• Detail-oriented and able to manage multiple projects at the same time
• Proficiency in Microsoft products
• Strong strategic thinking and problem-solving skills

Responsibilities

• Participate in planning, coordinating, and conducting all activities involved in initiating, monitoring, and completing clinical trials
• Ensure studies are conducted and documented in accordance with the study protocol, study plans, standard operating procedures, good clinical practices, and other applicable regulatory requirements
• Facilitate the execution of startup activities and study maintenance (eg, collection of regulatory documents and ethics submissions, shipment of supplies and equipment, vendor training/access to vendor portals); to ensure site readiness and study maintenance
• Responsible for in-house and clinical site monitoring deliverables (e.g., performing source data verification, identifying protocol deviations and safety events, conducting site training, and providing written follow-up requests to correct any issues identified)
• Generate monitoring reports
• Establish and maintain biobanking program
• Coordinate and track sample shipments with biopharma partners, research institutions, and clinical research organizations (CROs); including reconciling manifests and total number of samples received
• Compare contracted sample numbers with the number of received samples and reported results and integrate all sample information into Salesforce, Foresight’s Customer Relationship Management system (CRM)
• Work to continuously improve the laboratory services process and identify opportunities for enhancement, collaborating with operational and engineering teams to develop solutions and facilitating delivery of workflow improvement
• Monitor aggregate data relating to clinical trial testing, including specimen acceptance rates and QC failure rates
• Manage and resolve specimen or data issues with Sponsor, CRO, or other study partners
• Participate in partner meetings, as needed
• Update all relevant tracking systems and logs on an on-going basis
• Maintain the internal trial master file
• Maintain and update clinical operations documents that govern trial conduct

Preferred Qualifications

Laboratory operations experience is preferred

Benefits

• Paid vacation
• Sick time
• Parental leave (if applicable)
• Medical, dental, vision, life, disability coverage
• Flexible spending accounts
• A 401k with company match
• Bonus and equity offerings