[Hiring] Senior Clinical Research Associate @Alira Health

Role Description

The Sr CRA is an important member of the Alira Health Clinical team. The Sr CRA is highly motivated and functions independently to conduct site monitoring responsibilities for clinical trials, as well as providing oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. The Sr CRA works closely with:

• US: Director of Clinical Monitoring
• Lead CRAs
• In-house CRAs
• EU: Associate Director of Clinical Monitoring
• CRAs
• Project Managers

to ensure protocol compliance, address site questions, and assist with study recruitment, site training, and other site-related issues.

Qualifications

• US: BS/BA from an undergraduate program (life sciences or related discipline preferred)
• US: 3 years of experience in the pharmaceutical/biotechnology/CRO industry, 2 years of clinical monitoring experience with 1 year of management experience
• EU: Minimum 2 years of clinical monitoring experience in the pharmaceutical/biotechnology/CRO industry and ability to autonomously manage monitoring activities

Requirements

• Quality focused; 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
• Able to manage priorities, organize time, and solve problems
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• Ability to travel
• Ability to manage stress
• Professional, trustworthy, and disciplined
• Ability to problem-solve unstructured or ambiguous challenges
• US: Strong command of English, both written and verbal
• EU: Strong command of local language, both written and verbal, in the country where monitoring activities are performed
• Excellent communication and interpersonal skills with customer service orientation
• Good computer skills, with ability to use clinical trial management systems, clinical trial databases, and electronic data capture
• Self-starter who thrives in a collaborative, yet less structured team environment
• Knowledge of clinical research, ICH GCP, and local regulations
• Knowledge of regulatory and ethical requirements
• Ability to establish and maintain positive relationships with Sponsor, Site, and Project Team members
• US: Permanent authorization to work in the U.S.
• EU (Italy): Certified Monitor in compliance with Italian CRO decree dated 15Nov2011
• EU: Graduation in a scientific health field
• EU: Adequate English

Benefits

• The final offer will be determined within the applicable location-specific range
• Will depend on the candidate’s confirmed work location, relevant experience, skills, qualifications, internal equity, and role scope