Clinical Research Associate

Join our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others.

Job Description Summary Job Description ROLE 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

• 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.

DESIRED QUALIFICATION & EXPERIENCE

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

TECHNICAL COMPETENCES & SOFT SKILLS

• 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.

Languages English Education Bachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences

Contract Type Regular Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle. With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork. We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience.

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