Position Summary

The Clinical Research Associate is responsible for the initiation and oversight of clinical evaluations in support of BioFire Defense in vitro diagnostic (IVD) products. They are the primary liaison between BioFire Defense and clinical study sites. They work closely with research personnel to ensure the integrity and safeguarding of clinical study data. They are also responsible for assisting Clinical Research Scientists in the initiation and training of new clinical sites, as well as monitoring and auditing sites throughout the course of the study ensuring compliance to study protocols, Good Clinical Practices (GCPs), Federal Regulations, company procedures, and other applicable regulatory requirements.

Other key skills required

• Excellent interpersonal skills and ability to work with a broad range of clinical personnel (physicians, laboratory directors, laboratory staff, volunteer participants, etc.).
• Ability to travel (up to 30%) to initiate and monitor clinical sites.
• Excellent writing and communication skills.
• Ability to collaborate in a fast-paced environment.
• Ability to execute, monitor, and status projects.

• May be required to obtain and maintain a DoD Personnel Security Clearance.

   

Education and Experience

Minimum of a bachelor's degree with emphasis in a science, or related field.

• Experience with molecular biology laboratory techniques, including PCR.
• Proficiency with Microsoft Suite.
• Preferred but not required experience:
  • Clinical study administration or management (e.g. electronic data capture system and electronic trial master file development and maintenance)
  • Knowledge of Good Clinical Practices
  • Knowledge or previous training in Human Subjects Protections