Clinical Research Associate II

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

Benefits:

• Medical
• Dental
• Vision
• 401k - company match of 5% regardless of participation and up to a total of 9.5% company match if contributing 
• 4 Weeks of PTO
• 9 Paid Holidays
• Paid Winter Break from the work week between December 24 thru December 31 
• Participation in Company's Wellness Program (discounted medical premiums)
• Multiple Company Sponsored Events Each Year (catered breakfast/lunch, holiday parties, snacks)
• Stimulating work environment
• Convenient location near I-15 and Trax Station
• Free Parking

Our EEO Policy

BioFire Defense is an equal opportunity employer (M/F/D/V). We recruit, employ, train, compensate, and promote without regard to race, religion, creed, color, national origin, age, gender, sexual orientation, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law. BioFire Defense complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.