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

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 Assistant (CA) is an important member of the Clinical Operations team. Under supervision, the CA provides support to the Clinical Operations team during the start-up, execution, and close-out of clinical studies, including a variety of supportive clinical trial management tasks. The CA will quickly develop a basic understanding of study protocols, standard operating procedures (SOPs), and Good Clinical Practice (GCP).

ESSENTIAL JOB FUNCTIONS*

• Prepares meeting materials, attends meetings, and prepares meeting minutes
• Assists with preparing and assembling study documents and materials
• Ships study materials to participating clinical sites
• Reviews regulatory documents for proper completion
• Assists with site communication and responds to sponsor requests
• Assists with maintenance of Trial Master Files (TMFs)
• Collaborates in the preparation of weekly/monthly and ad hoc project reports
• Tracks protocol deviation logs, monitoring visits, and visit reports as needed
• Answers the Alira Health Clinical main phone line
• Maintains study-specific trackers as needed
• Assists other team members with ad hoc tasks
• Complies with ICH GCP guidelines, FDA regulations, and company SOPs
• Participates in internal, client/sponsor, scientific, and other meetings as required
• Performs additional duties as assigned

PREPARATION, KNOWLEDGE, SKILLS & ABILITIES 

• BS/BA from an undergraduate program or equivalent experience
• 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
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• 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

Education

Contract Type

Regular