Job Title: Clinical Research Associate (CRA)
Location: Remote/Hybrid/Onsite (Boulder, CO)
Travel: Quarterly travel to Boulder, CO
Team: Clinical Operations
Type: Full‑time
Compensation: $115,000–$130,000 base + bonus + equity

About Foresight Diagnostics

Foresight Diagnostics is an early‑stage, venture‑backed molecular diagnostics company developing non‑invasive cancer detection technologies to improve patient outcomes worldwide. Built on proprietary, Stanford‑originated methods in cell‑free DNA and liquid biopsy, Foresight enables earlier detection of smaller tumors and more personalized treatment strategies. The company’s expertise spans molecular biology, bioinformatics, and NGS, with a dynamic, high‑impact environment and significant opportunities for growth. Headquarters: Boulder, Colorado.

Role Overview

As a Clinical Research Associate within Clinical Operations, you’ll help deliver clinical trials under an Investigational Device Exemption (IDE). You’ll monitor data, maintain the Trial Master File (TMF), respond to CRO/sponsor queries, and partner with internal teams and external stakeholders to ensure high‑quality execution. The role also supports sample logistics for translational research and investigator‑initiated trials, including biobanking and inbound/outbound coordination.

What You Will Do

  • Plan, coordinate, and conduct activities to initiate, monitor, and close clinical trials.
  • Ensure compliance with protocols, study plans, SOPs, GCP, and applicable regulations.
  • Facilitate startup and maintenance: collect regulatory/ethics documents, arrange supply shipments, and manage vendor training/portal access.
  • Perform in‑house and on‑site monitoring: SDV, protocol deviation and safety event identification, site training, and written follow‑ups.
  • Generate clear, timely monitoring reports.
  • Establish and maintain a biobanking program.
  • Coordinate and track sample shipments with biopharma partners, research institutions, and CROs; reconcile manifests and total samples received.
  • Compare contracted sample volumes with received samples and reported results; integrate all sample data into Salesforce (CRM).
  • Drive continuous improvement of laboratory services; collaborate with operations and engineering to enhance workflows.
  • Monitor aggregate testing metrics (e.g., specimen acceptance and QC failure rates) and act on trends.
  • Triage and resolve specimen/data issues with sponsors, CROs, and vendors.
  • Participate in partner meetings and keep all tracking systems and logs up to date.
  • Maintain the internal Trial Master File (TMF) and Clinical Operations documents governing trial conduct.

What You Will Bring

  • Bachelor’s or Master’s degree in a relevant field.
  • 5+ years in Clinical Operations, including monitoring and TMF management.
  • Certification in Good Clinical Practice (GCP) and Human Subjects Research.
  • Laboratory operations experience preferred.
  • Excellent written and verbal communication; strong attention to detail.
  • Ability to manage multiple projects simultaneously and meet deadlines.
  • Proficiency with Microsoft tools; Salesforce familiarity a plus.
  • Strong problem‑solving and strategic thinking skills.

Physical & Working Conditions

  • Learn new tasks, retain processes, maintain focus, and work independently within defined workflows.
  • Make timely decisions; communicate effectively with cross‑functional partners.
  • Travel at least quarterly to Boulder, CO.
  • Sedentary work; occasionally lift up to 10 lbs.
  • Requires close visual acuity for data analysis, transcription, extended computer use, and reading.

Compensation & Benefits

  • Base salary: $115,000–$130,000; eligible for bonus and equity.
  • Medical, dental, vision, life, and disability insurance.
  • Paid vacation, sick time, and parental leave (if applicable).
  • Flexible spending accounts; 401(k) with company match.
  • Professional development and growth opportunities with high‑impact projects.

Equal Opportunity

Foresight Diagnostics is 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.