Clinical Research Associate

Position Overview

• Location Type: Remote
• Employment Type: Full-time
• Salary: Not provided
• Job Type: Clinical Research Associate
• Summary: Alira Health is seeking a Clinical Research Associate to join their team. Candidates should have 2+ years of monitoring experience, including oncology.

Requirements

• 2+ years of monitoring experience
• Experience in oncology preferred
• Knowledge of ICH GCP guidelines and FDA regulations
• Strong understanding of clinical trial protocols

Responsibilities

• Provides guidance, oversight, and feedback to the CRA team.
• Reviews monitoring visit reports and conducts co-monitoring visits.
• Ensures appropriate and timely investigator site visits.
• Coordinates with cross-functional departments to resolve clinical trial monitoring issues.
• Assists in the development of study-specific Monitoring Plans and training presentations.
• Assists in the set up/collection of site specific ethics documents and site contract negotiation.
• Provides monthly billing information to the finance team.
• Manages study budget and acts as a referent for the sponsor for monitoring stand-alone projects.
• Performs qualification, initiation, interim, and close-out visits (remote and onsite).
• Prepares consistently accurate and timely monitoring visit reports.
• Ensures integrity of CRF data through source document review and verification.
• Performs quality control and verification of documents collected at sites for eTMF/TMF.
• Conducts investigational product accountability.
• Reviews site regulatory binder for required documents.
• Maintains regular contact with study sites.
• Complies with and ensures team compliance with ICH GCP guidelines, FDA regulations, and company/Sponsor SOPs.

Application Instructions

• If referred, apply using the referral link emailed.

Company Information

• Company: Alira Health
• Description: A global team dedicated to innovation and initiative, encouraging collaboration despite physical distance and time zone differences.
• Values: Be courageous, be accountable, be honest, be inclusive, and elevate others.