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 documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status; facilitating adverse event reporting and ensuring reconciliation of SAE reports with source documentation and CRFs; ensuring integrity of CRF data through meticulous and thorough source document review and verification; conducting investigational product accountability; reviewing regulatory binder for required documents; working closely with in-house CRAs and data management to resolve queries on discrepant data; 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 as needed; working with other CRAs to maintain consistency and promote a collaborative team atmosphere; managing and resolving conflicting priorities to deliver on commitments; 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 from an undergraduate program or equivalent experience and 2 years of clinical research experience. Technical competences and soft skills required include ability to travel, being careful, thorough, and detail-oriented, strong organizational skills, ability to multi-task and work effectively in a fast-paced environment, self-starter who thrives in a collaborative yet less structured team environment, ability to problem-solve unstructured or ambiguous challenges, strong command of English both written and verbal, excellent communication and interpersonal skills with customer service orientation, proficiency with MS Office Suite particularly Word and Excel, and permanent authorization to work in the country where applying.
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