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Director of Clinical Research

Company: BioIntelliSense , Inc.
Location: Denver
Posted on: May 16, 2022

Job Description:

Description:
About BioIntelliSenseBioIntelliSense is ushering in a new era of continuous health monitoring and clinical intelligence for Remote Patient Monitoring (RPM). Our medical-grade Data-as-a-Service (DaaS) platform seamlessly captures multi-parameter vital signs, physiological biometrics and symptomatic events through an effortless patient experience. The FDA-cleared BioSticker--- and BioButton--- devices make remote monitoring and early detection simple. Through the platform's advanced analytics, clinicians, patients and employers will now have access to high-resolution patient trending and reporting to enable medical-grade care at home, and medical-grade screening in the office, school or residence. For more information on how BioIntelliSense is redefining remote patient monitoring through medical-grade and cost-effective data services, please visit our website at BioIntelliSense.com. We are seeing hyper growth and expanding our research team! We are looking for an experienced Clinical Research Program Manager who is excited about joining a fast-paced startup and building something great.About the RoleWe are seeking a Director of Clinical Research to oversee the facilitation and coordination of clinical trial activities involving BioIntelliSense's products. The ideal candidate have experience with IRB studies and will work with company leadership and individual study principal investigators (PIs) to ensure that study protocols are developed in alignment with company research objectives and are executed according to Good Clinical Practice. With support of Clinical Research project management, the candidate will be responsible for managing a portfolio of studies executed through collaboration of various internal stakeholders and external clinical partners. Specific job duties include:

  • Overseeing the execution of clinical trials, from protocol development to final analysis and reporting
  • Communicating objectives and timelines clearly with internal stakeholders and external clinical partners
  • Monitoring each study to ensure that it complies with protocols, is ethically conducted, and follows regulatory standards
  • Maintaining research records of study activities using clinical research software
  • Coordinating the implementation of clinical studies by training on-site study staff to administer study materials and devices
  • Communicating progress and issues to study investigators, relevant institutional review boards, and internal stakeholders
  • Supervising clinical study project managers and/or research assistantsThis is a unique opportunity to apply your experience, roll-up-your-sleeves, and significantly contribute to the rapid development, growth and expansion of BioIntelliSense in delivering clinical intelligence, globally.

    Requirements:
    What We Are Looking For
    • BS or MS in a clinical or health-related field of study required
    • 10 years' experience overseeing clinical research/ trials
    • Must have experience managing IRB studies
    • CCRC certification is required
    • Experience with medical device, digital health technology or pharmaceutical clinical trials required
    • Proven experience partnering with clinicians, practitioners and researchers
    • Experience writing detailed research summaries and designing research protocols
    • Strong oral and written communication and collaboration skills
    • Management experience with ability to build and lead a team required
    • Proficiency with MS Office software like Word, Excel, and PowerPoint
    • Exceptional attention to detail
    • Ability to work under pressure in a startup environment
    • Knowledge of statistical methods and their application in clinical research is a plusJob Type: Full-time - ExemptSalary Expectations: $120-160K total compensation (based on experience)Work Location: Onsite - Golden, CO officeYou're excited about this opportunity because you will---
      • Join a fast-growing company and grow right along with us.
      • Work on challenging and interesting tech problems which reshapes the future of healthcare.
      • Get the chance to work on cutting-edge technologies and use world-class tooling to get the job done.
      • Make a large impact across the company through business deliverables and continuous innovation.
      • Opportunity to build solutions and organizations from 0 to 1.Why You'll Love Working at BioIntelliSense
        • We are leaders - Leadership is not limited to our management team. It's something everyone at BioIntelliSense embraces and embodies.
        • We are doers - We believe the only way to predict the future is to build it. Creating solutions that will lead BioIntelliSense and healthcare industry is what we do - on every project, every day.
        • We are learning - We're not afraid to dig in and uncover the truth, even if it's scary or inconvenient. Everyone here is continually learning on the job, no matter if we've been in a role for one year or one minute.
        • We have great benefits - Medical/Dental/Vision/Life (at little to no cost to the employee), Disability (STD & LTD), 401(k) matching, 10 Paid holidays a year, generous vacation paid time off**BioIntelliSense is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran, disability status or any other status protected under federal, state or local law.PI174477399

Keywords: BioIntelliSense , Inc., Denver , Director of Clinical Research, Executive , Denver, Colorado

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