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Clinical Research Associate Apply locations Boston-Remote time type Full time posted on Posted 30+ Days Ago job requisition id JR000112

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

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.

Job Description

THE Clinical Research Associate (CRA) Role

The CRA 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 and Clinical Project Managers to ensure sites’ protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

ESSENTIAL JOB FUNCTIONS*

• 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

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES 

• 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.

WORKING CONDITIONS/PHYSICAL DEMANDS

Normal office working conditions including frequent sitting, standing, bending, twisting and computer monitor use. Occasional lifting of weight up to 30 lbs.

Languages

English

Education

Contract Type

Regular

About Us

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.

Why Work at Alira Health?

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.

Join Our Team

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.

Introduce yourself to our Recruiters! Apply to one of our open jobs or send us your spontaneous application.

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