Senior Clinical Research Associate

IRE • Us, CO

7d

About The Position

The Senior Clinical Research Associate will work in ICON Strategic Solutions’ sponsor-dedicated model, supporting Dermatology and Rare Disease trials. The role involves working in a large-scale, fast-paced environment with a team of CRAs to identify, select, initiate, monitor, and close out investigational sites for Phase II–IV studies while ensuring compliance with applicable regulations and ICH-GCP principles. The position also includes independent study work, documentation and reporting, study cost efficiency, and possible training and mentoring of fellow CRAs.

Requirements

• At least 18 months of CRA monitoring experience in Phase I–III trials.
• 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 skills in German and English.
• Ability to work to tight deadlines.
• Availability to travel at least 60% of the time, domestically and internationally, by air and car.
• Valid driving license.

Responsibilities

• Independently and proactively set up and monitor studies, complete reports, and maintain documentation.
• Submit protocols and consent documents for ethics committee or IRB approval and prepare regulatory submissions.
• Balance sponsor-generated queries.
• Take responsibility for study cost efficiency.
• Prepare and review study documentation and feasibility studies for new proposals.
• Potentially assist in training and mentoring fellow CRAs.
• Identify, select, initiate, and close out investigational sites for clinical studies.
• Ensure adherence to applicable regulations and ICH-GCP principles.

Benefits

• Competitive base salary and performance-related incentives.
• Health and wellbeing programmes, including medical, dental, and vision coverage where applicable.
• 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.
• Annual bonuses reflecting performance goals.
• Competitive salary packages benchmarked against competitors.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Associate degree