Note: The job is a remote job and is open to candidates in USA. ICON Strategic Solutions is hiring a Senior Clinical Research Associate in a sponsor-dedicated model supporting Dermatology & Rare Disease trials. The role oversees clinical study sites from selection and initiation through close-out, monitors studies, prepares regulatory and study documentation, and ensures compliance with applicable regulations and ICH-GCP.

Responsibilities

• As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP
• Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
• Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
• Balancing sponsor generated queries
• Taking responsibility for study cost efficiency
• Preparation and review of study documentation and feasibility studies for new proposals
• Potential to assist in training and mentoring fellow CRAs

Skills

• 18 months+ of monitoring experience in phase I-III trials as a CRA
• College degree in medicine, science, or equivalent
• Previous monitoring experience in medium-sized studies, including study start-up and close-out
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent written and verbal communication in German & English
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based

Benefits

• Remote work
• Annual bonuses reflecting delivery of performance goals – both ours and yours
• Performance related incentives
• Health-related benefits for employees and their families
• Medical, dental, and vision coverage where applicable
• Competitive retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

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