Clinical Study Coordinator

At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time. We use machine learning and microfluidics to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection. We’re looking for a Clinical Study Coordinator to join our team and support clinical studies for our in vitro diagnostic (IVD) products. In this role, you’ll help drive studies that generate critical data for regulatory approvals and market adoption, working closely with clinical sites, cross-functional teams, and external partners. Your work will directly contribute to bringing life-saving diagnostic solutions to patients faster and more efficiently. Goals

Within your first 90 days:

• Onboard to Pattern Bioscience’s clinical research processes and systems.
• Develop a thorough understanding of ongoing and planned IVD studies.
• Begin supporting sample and supply management, monitoring, and study support activities including review and filing in the Trial Master File.
• Assist CRAs in training of external study sites.

Within 6 months:

• Independently coordinate Pattern’s internal sample bank and communication with sites contributing to the repository.
• How You Will Contribute
• Support day-to-day operations of IVD clinical studies, ensuring protocol compliance and regulatory adherence.
• Serve as a liaison for investigational sites, fostering strong relationships and providing timely support.
• Support site visits—including initiation, monitoring, and close-out—to ensure data integrity and protocol compliance.
• Oversee accurate and timely collection of study data and biological specimens.
• Contribute to the preparation of study reports and process documentation.
• Maintain essential documents and regulatory files in an audit-ready state.
• Ensure compliance with regulatory requirements.
• Support CRAs and the clinical team with clinical study documentation.

Contribute to process improvements for clinical study operations. We’d Love to Hear from You If You Have strong organizational skills and can juggle multiple priorities effectively. Enjoy working both independently and collaboratively in a fast-paced environment. Communicate clearly and professionally with diverse stakeholders in both oral and written formats. Are comfortable traveling up to 50%, with potential peaks up to 75% during key study phases. Are passionate about contributing to innovative solutions in healthcare and diagnostics. Desired Education and Experience Bachelor’s degree in life sciences, biomedical engineering, medical technology, or a related field. 1-3 years of clinical research experience, ideally in IVD or medical device trials. Knowledge of FDA regulations, GCP, ISO 14155, and IVDR requirements for IVD clinical studies. Skills or Attributes Considered a Plus Clinical research certification (e.g., CCRC, CCRP). Experience with electronic data capture (EDC) systems. Previous experience working on diagnostic microbiology or infectious disease studies. This is a remote position, but we are currently only able to hire team members based in Florida, Maryland, Massachusetts, Missouri, New York, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Texas, Utah, Washington, or West Virginia. Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website. Benefits Health insurance 401k Matching Paid Time Off The opportunity to make a global impact To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and an environment where people love coming to work. We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.