In-House Clinical Research Associate-2

The In-house CRA is an important member of the Alira Health Clinical team, managing and supporting clinical sites from site approval through close-out, with a focus on ensuring the integrity of trial data without frequent travel.

Requirements

• Develops study documents and tools
• Supports sites in obtaining IRB approval and developing submission materials
• Responds to sites' regulatory board requests for protocol and ICF clarification
• Ensures all required site regulatory documents and approvals are in place
• Conducts routine file reviews and collects and files regulatory documents
• Analyzes site performance problems and identifies solutions
• Provides ongoing training for study sites
• Maintains regular communication with study sites
• Conducts remote review of data entered on electronic Case Report Forms
• Works closely with field CRAs and data management to resolve queries on discrepant data
• Assists with efforts to recruit investigative sites to participate in clinical studies
• Complies with ICH GCP guidelines, FDA regulations, and company SOPs

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Health Insurance
• Dental Insurance
• Vision Insurance