Job Description

The Clinical Research Associate is an important member of the Alira Health Clinical team. CRAs are highly motivated and function independently to conduct site monitoring responsibilities for clinical trials. CRAs work closely with the In-house CRAs, Lead CRAs, Director of Clinical Monitoring and Project Managers to ensure sites’ protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues. Key responsibilities include performing qualification, initiation, interim, and close-out visits and ensuring proper documentation of site visits; preparing accurate and timely monitoring visit reports; facilitating adverse event reporting and ensuring reconciliation of SAE reports; ensuring integrity of CRF data through thorough source document review; conducting investigational product accountability; reviewing regulatory binder for required documents; working closely with in-house CRAs and data management to resolve queries; proactively identifying site issues and developing problem-solving strategies; maintaining regular contact with study sites to ensure protocol/GCP compliance, assessing patient accrual rates, and responding to sponsor requests; conducting audit preparation at study sites; working with other CRAs to maintain consistency and promote a collaborative team atmosphere; managing and resolving conflicting priorities; complying with ICH GCP guidelines, FDA regulations, and company SOPs; participating in industry and client meetings; and performing additional duties as assigned. Desired qualifications include a BS/BA or equivalent experience and 2 years of clinical research experience. Technical competencies include ability to travel, attention to detail, strong organizational skills, ability to multi-task, self-starter attitude, problem-solving skills, strong command of English, excellent communication and interpersonal skills, proficiency with MS Office Suite, and permanent authorization to work in the country of application.

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