Clinical Research Associate Minnesota

FloodGate Medical
  • Tampa, Florida
    20 days ago

    Job Description

    "At Mobius, we only hire the best of the best. Our people are the primary reason for our success and the first pillar of our core values. As a leading CRO managing clinical trials across the USA, Australia, and New Zealand, we support a diverse portfolio of global and local clients across all phases of development and an array of therapeutic goods. We are committed to supporting our partners through every step of the clinical project journey, from rapid start-ups and comprehensive monitoring to precise data management, in-house EDC, and expedited study close-out."

    Clinical Research Associate / Senior CRA | Mobius Medical | Minneapolis, MN

    About Mobius

    Mobius Medical was founded in 2008 on a simple frustration: too many medical breakthroughs were being held back not by the science, but by trials built for pharma scale that didn’t fit the realities of MedTech. So the founders built a CRO that does one thing and does it exceptionally well. Medical devices, nothing else.

    Nearly two decades later, Mobius has run 140+ trials across 27+ therapeutic areas, from first in human feasibility through pivotal approvals and post market. Cardiovascular and structural heart are core strengths, alongside neuro, women’s health, orthopedics, and more. The company has grown almost entirely through repeat business and referrals, partnering with global device leaders and innovative startups alike, and holds ISO 9001 certification with operations across the USA, Australia, and New Zealand.

    Mobius opened its U.S. headquarters in Minneapolis in 2023, right in the heart of one of the strongest MedTech hubs in the world. The U.S. team is lean, founder led, and growing fast. That means no layers of bureaucracy, direct access to leadership, and decisions that get made in days, not quarters.

    Why Now

    This is a team in build mode. Mobius recently signed a large 40 site randomized clinical trial, is supporting a rescue study alongside its ongoing portfolio, and has four additional projects in the pipeline starting between Q4 2026 and Q3 2027. The CRAs who join now won’t just monitor sites. They’ll help shape how the U.S. operation runs as it scales.

    The Role

    As a CRA or Senior CRA at Mobius, you’ll be the primary site manager across a variety of device studies, owning the full lifecycle from planning and startup through monitoring and closeout. Think of it as a mini PM seat: real autonomy, real accountability, and real visibility with sponsors and leadership. If you’ve ever felt like a cog in a big CRO machine, this is the opposite.

    What You’ll Do

    • Own clinical trial execution from planning and startup through monitoring and closeout
    • Partner with the VP and Manager of Clinical Operations to shape your project portfolio, monitoring schedules, and scope
    • Execute studies in line with Mobius SOPs, study plans, GCP, and applicable regulations
    • Build trusted relationships with investigators and site teams, helping them deliver high quality data and strong compliance
    • Troubleshoot site and study issues and find compliant, practical solutions
    • Run regular project meetings and manage status reporting to sponsors
    • Support budgeting, timekeeping, and billing
    • Mentor colleagues and share what you know as the team grows
    • Keep sharpening your edge through ongoing training and professional development

    What You Bring

    • Bachelor’s degree in life sciences or a related field; clinicians who have transitioned into clinical research are strongly encouraged to apply
    • 3+ years of CRA experience in medical devices, with cardiovascular device experience a strong plus
    • Working command of the clinical trial lifecycle, including FDA and IDE studies, IRB submissions, TMF, GCP, site management, monitoring, and audit readiness
    • Comfort with EDC, CTMS, and study specific systems and tools
    • A self starter who asks good questions, challenges the team when it matters, and is happy wearing multiple hats
    • Strong communication skills with sponsors, sites, and internal teams
    • Comfort with regular travel, typically 1 to 2 trips per week depending on project

    Compensation

    • Competitive base salary, depending on experience
    • Benefits: medical, dental, and vision, with the company paying 70% of the premium
    • 160 hours of PTO and 48 hours of sick leave annually
    • 401(k) with a 4% match

    Location

    Minneapolis, MN area, remote with travel.

     
     

    Numbers & Facts

    LocationTampa, Florida
    Websitehttps://floodgatemedical.com

    Skills

    • Billingunmatched
    • Biologyunmatched
    • Biotech and Pharmaceuticalunmatched
    • Budgetingunmatched
    • Cardiovascularunmatched
    • Clinical Researchunmatched
    • Clinical Trialunmatched
    • Clinical Trial Managementunmatched
    • Communication Skillsunmatched
    • Contract Research Organization (CRO)unmatched
    • Data Managementunmatched
    • Data Qualityunmatched
    • Electronic Data Capture (EDC)unmatched
    • FDA (Food and Drug Administration)unmatched
    • GCP (Good Clinical Practices)unmatched
    • Hubsunmatched
    • Hyperion Pillarunmatched
    • IDE (Integrated Development Environment)unmatched
    • IRB/IEC (Institutional Review Board/Independent Ethics Committee)unmatched
    • ISO 9001unmatched
    • Identify Issuesunmatched
    • Leadershipunmatched
    • Medical Equipmentunmatched
    • Mentoringunmatched
    • Operations Managementunmatched
    • Orthopedicsunmatched
    • Project Trackingunmatched
    • Standard Operating Procedures (SOP)unmatched
    • Startupunmatched

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