Avania is hiring - Clinical Trials Lead (Lead Clinical Research Associate!)
As a Clinical Trials Lead (Lead Clinical Research Associate), you will work with a sponsoring company in monitoring medical device and MedTech studies, ensuring the highest ethical and clinical standards.
You will supervise project-specific monitoring activities, coordinate training, interact with clients, and act as the primary contact for study questions. You will organize team training, generate monitoring tools, and ensure visits are conducted properly and tasks completed timely. You will also review study documentation for accuracy and quality, and represent Avania in conference calls and meetings.
The Lead CRA collaborates with the Project Manager to meet study objectives and may handle CRA activities as needed. You will support CRAs, assist with challenging situations, conduct co-visits, review reports, and perform similar tasks.
This position requires travel of approximately 25-30%.
We seek candidates with :
* RN or BA / BS in a science, engineering, or health-related field plus at least 4 years of monitoring experience
* Knowledge of clinical research terminology, EU / US regulations, ICH / GCP Guidelines, ISO 14155, and ability to learn across therapeutic areas
* Experience mentoring and training new CRAs
* Ability to conduct monitoring visits and complete documentation
* Organizational, time management, and problem-solving skills
* Excellent communication and professional writing skills
* Computer proficiency, especially in Excel
* Experience creating training presentations and coordinating training
* Strong relationship-building skills and team orientation
* Ability to generate monitoring tools and deliver presentations
* Ability to address questions and escalate issues to sponsors
* Clinical research certification is a plus
We offer :
* Opportunity to work in a fast-growing, innovative industry
* Collaborative global team environment
* Knowledge exchange, training, and career development
* Competitive compensation and benefits
* Potential for travel
* Hybrid and remote work options available
We look forward to receiving your application!
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