Clinical Research Associate

Job Summary

The Clinical Research Associate (CRA) is a key member of the Alira Health Clinical team, responsible for conducting site monitoring for clinical trials and ensuring protocol compliance.

• Perform qualification, initiation, interim, and close‑out visits and document findings accurately.
• Prepare monitoring visit reports detailing site problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
• Facilitate adverse event reporting and reconcile SAE reports with source documentation and CRFs.
• Ensure CRF data integrity through meticulous source document review and verification.
• Conduct investigational product accountability.
• Review regulatory binder for required documents.
• Collaborate with in‑house CRAs, data management, and Project Managers to resolve data queries.
• Identify site issues proactively and develop problem‑solving strategies.
• Maintain regular contact with study sites to ensure GCP compliance and assess patient accrual rates.
• Prepare audit readiness at study sites as needed.
• Promote consistency and teamwork within the CRA team.
• Manage conflicting priorities and deliver on commitments.
• Comply with ICH GCP guidelines, FDA regulations, and company SOPs.
• Participate in industry and client meetings.
• Perform additional duties as assigned.

• BS/BA in an undergraduate program or equivalent experience.
• 2 years of clinical research experience.

• Ability to travel.
• Attention to detail, thoroughness, and strong organizational skills.
• Proficiency in MS Office Suite, especially Word and Excel.
• Strong command of English (written and verbal) and excellent communication and interpersonal skills.
• Self‑starter who thrives in a collaborative, fast‑paced environment.
• Problem‑solving ability for unstructured or ambiguous challenges.
• Permanent authorization to work in the country where you are applying.

Regular

English