Medical Affairs Research Associate I

Description

At BioFire Diagnostics, LLC. we make the world a healthier place by providing molecular solutions that lessen the time to medical results and empower healthcare professionals to make better diagnostic decisions.

We are proud to be part of the bioMérieux family and the 5,000+ team members across 12 sites and subsidiaries in North America committed to our mission to help save lives around the globe through the power of diagnostics.

Come be a part of our team and our mission as a Medical Affairs Research Associate!

Job Summary

The Medical Affairs Research Associate (RA) works under the supervision of the Director to manage investigator-initiated and company-sponsored studies conducted using BioMérieux BioFire products. For investigator-initiated studies, the RA is responsible for working with internal and external stakeholders to coordinate study efforts, to maintain study records and documentation, and to perform and document site initiation and study monitoring visits. For company-sponsored studies, the CRA is the primary liaison between BioMérieux and clinical study site personnel. The RA helps to ensure that all aspects of clinical studies are performed in accordance with the study protocol, human subject protections and with other applicable regulatory requirements.

• Perform all work in compliance with company quality procedures and standards.
• Schedule, management, and documentation of study review meetings.
• For investigator-initiated studies, the RA is responsible for:
  1. Supporting the Director in the review and execution of studies
  2. Track and document study progress
  3. Maintain study documents
  4. Perform and document site initiation and study monitoring visits, as needed
• For company-sponsored studies, the RA is BioMérieux’s liaison with regards to the studies and is responsible for:
  • Supporting the designated study lead
  • Communication with clinical study sites
  • Remote and on-site monitoring study site activities to ensure study compliance
  • Providing logistical, technical, and regulatory support to both BFDX and study site personnel to ensure that all parties have the necessary equipment, training, and materials to fulfill their role in the studies
  • Maintenance of study documents
  • Contributing to study procedures and final study reports
  • Real-time monitoring/management of site inventory/supplies to ensure sufficient resources are available to avoid study interruptions

• Actively contributes to the improvement of study-related processes and procedures.
• May participate in scientific conferences and contribute to scientific journals.
• Maintain expertise in human subject protection and IRB-related guidelines related to company-sponsored or supported studies.
• Maintains current knowledge of IHC/GCP and works towards ACRP (or equivalent) certification.
• Performs other duties as assigned.

Supplemental Data

• This position requires excellent written and oral communication skills.
• Excellent interpersonal skills and the ability to work with a wide variety of people (physicians, laboratory directors, laboratory staff, etc.) involved in conducting clinical studies.
• The ability to work closely with management and Medical Science specialists to identify and communicate areas of technical, schedule, and budget risk.
• Excellent organizational skills are essential.
• Some driving within Salt Lake County may be required. Must provide own transportation.
• Domestic and international travel required – up to 30%

Training and Education

• Minimum of a Bachelor’s degree in Biology, Microbiology, or related field.  

Experience

• Minimum of 2 years experience with clinical studies and/or molecular biology laboratory techniques and/or clinical studies. Preferred experience with BioFire diagnostic platform.

Knowledge, Skills and Abilities

• Strong computer skills, including word processing and the use of spreadsheets.
• Skills with database and project management software desirable.
• Demonstrated ability to independently manage projects and report areas of risk as they arise.

Physical Requirements

• Ability to lift up to 40 lbs.