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.
Performs qualification, initiation, interim, and close-out visits and ensures proper documentation of site visits.
Prepares consistently accurate and timely monitoring visit reports documenting site-related problems, resolutions, actions taken, protocol deviations, study progress, and enrollment status.
Facilitates adverse event reporting and ensures the reconciliation of SAE reports with source documentation and CRFs.
Ensures integrity of CRF data through meticulous and thorough source document review and verification.
Conducts investigational product accountability.
Reviews regulatory binder for required documents.
Works closely with in-house CRAs and data management to resolve queries on discrepant data.
Proactively identifies site issues and develops problem-solving strategies for sites.
Maintains regular contact with study sites to ensure protocol/GCP compliance, assesses patient accrual rates, and responds to sponsor requests.
Conducts audit preparation at study sites as needed.
Works with other CRAs to maintain consistency and promote a collaborative team atmosphere.
Manages and resolves conflicting priorities to deliver on commitments.
Complies with ICH GCP guidelines, FDA regulations, and company SOPs.
Participates in industry and client meetings.
Performs additional duties as assigned.
BS/BA from an undergraduate program or equivalent experience
2 years of clinical research experience
Ability to travel.
Proven ability to be careful, thorough, and detail-oriented.
Strong organizational skills and the 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.
Proficient with MS Office Suite, particularly Word and Excel.
Permanent authorization to work in the country where you are applying.
Alira Health...Clinical Research Associate The Clinical Research Associate (CRA) is responsible for overseeing the operational aspects of clinical trial conduct at investigational sites to ensure data integrity, regulatory compliance, and adherence to Good Clinical Practice (GCP)...
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