Clinical Research Associate

ABOUT ALIRA HEALTH
At Alira Health, our mission is to enable healthcare transformation. Our team collaborates fully to understand every aspect of each client’s organization from concept ideation to commercial realization, from innovation to implementation. We support our clients with a full spectrum of patient-centric data and tech-enabled services including Transaction Advisory, Management Consulting, Real-World Evidence, Advanced Analytics, Patient Engagement, Product Development, Regulatory, Clinical, and Market Access.
Our clients are global, and so are we. Our local presence and global collaboration allow us to deliver actionable business insights and an unmatched continuum of support across the full corporate and product lifecycle. We operate across thirteen offices located in Boston and San Francisco in the US; Barcelona, Basel, Bologna, Geneva, Milan, Munich, Paris, and Verona in Europe; Cambridge, United Kingdom; Sydney, Australia; and Toronto, Canada.

• 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 U.S.

English Regular