Position Summary

The Clinical Data Specialist assists the Clinical Team in the analysis of study data in support of BioFire Defense in vitro diagnostic (IVD) products. They provide input on study protocols, data collection, and data formatting. They also ensure that data is collected in adherence to study protocols, Good Clinical Practices (GCPs), Federal Regulations, company procedures, and other applicable regulatory requirements. They are also responsible for communicating up-to-date analyses of data throughout the course of the study, assisting in the investigation of any identified data discrepancies, and summarizing data for reports.

Other key skills required:

• Excellent interpersonal skills and ability to interact with a broad range of clinical personnel (physicians, laboratory directors, laboratory staff, volunteer participants, etc.).
• Excellent writing and communication skills.
• Ability to collaborate in a fast-paced environment.

Education

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

Experience

• Travel may be required (up to 30%) to visit clinical sites.
• Proficiency with Microsoft Suite is required.
• Proficiency with data analysis tools such as Excel, R, SQL, or Python is required.
• Preferred but not required experience:
  • Experience with molecular biology laboratory techniques (e.g., PCR)
  • Experience in analyzing large datasets
  • Knowledge of Good Clinical Practices (GCP)
  • Knowledge or previous training in Human Subjects Protections
• May be required to obtain and maintain a DoD Personnel Security Clearance.