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. Key Responsibilities 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. Desired Qualifications & Experience BS/BA in an undergraduate program or equivalent experience. 2 years of clinical research experience. Technical Competences & Soft Skills 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. Contract Type Regular Languages English #J-18808-Ljbffr
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