[Remote] Senior Clinical Research Associate
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
Company Overview