Petros Inc is a search firm in the medical device and biotech space.  We have partnered with Miromatrix Medical, a mid-sized biotechnology company based in the Minneapolis area to recruit a Clinical Research Associate.  This company is looking to revolutionize the organ transplant industry by giving acute liver failure patients more options and end the transplant waiting list.

NOTE: This is NOT a ‘typical’ CRA role that you may be familiar with as the uniqueness of the product will influence aspects of the trial.  This is definitely not a ‘check the box’ type of role.

In this key role you will report to and work closely with the Sr Manager of Clinical to manage all aspects of the clinical trials.

Responsibilities include, but not limited to:

  • Ensure compliance with FDA regulations and standards for clinical research.
  • Manage our eTMF and CTMS systems to ensure that we are always ready for an FDA audit.
  • You will be involved in developing study protocols, case report forms, informed consents, and other critical documents supporting our sponsored clinical trials.
  • Oversite of our EDC system, review data, and issue and resolve data queries to ensure top-notch data quality.
  • Travel to our clinical sites and conduct site qualification and initiation, training, monitoring, and close-out activities.   Travel could average 30-40% with peaks up to 50%.
  • Conduct on-site monitoring by reviewing eCRFs, source documents, medical records, and regulatory documents.
  • Interact with our clinical sites participating in our studies by phone or email.
  • Support site initiation activities, audits, and site audit preparation in anticipation of site inspections.
  • Develop tools and materials for site training and education.

Candidates MUST live in the Minneapolis/St Paul area as this is primarily an office-based role.  Company is located in Eden Prairie.  Hybrid is not an option at this time but could evolve over time.

Qualifications:

  • A minimum of a bachelor’s degree in biology-related science, nursing, biomedical engineering, or other relevant disciplines with at least 1-3 years of experience supporting. clinical research in the medical device or pharmaceutical industry.
  • Experience with onsite monitoring is a major plus.
  • Have a clear understanding of the clinical trial process from beginning to end and everything in between.