Senior Clinical Research Associate
October 30
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. • Provides oversight, leadership, and guidance in the management and execution of clinical trials to ensure compliance and quality. • Works closely with the Director of Clinical Monitoring, Lead CRAs, in-house CRAs, Associate Director of Clinical Monitoring, CRAs, and Project Managers.
Requirements
• 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 • 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.
Benefits
• professional development • global travel • flexible work programs
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