Senior CRA

The Company
The Company is a pioneering MedTech company developing the first-in-class structural heart valve. We seek a passionate Sr. Clinical Research Associate to join our growing team. You'll play a pivotal role in managing a global pivotal trial across Europe, ensuring its success and advancing this groundbreaking therapy.

The Role
You'll oversee daily operations at investigational sites across Europe for our pivotal trial. This includes ensuring compliance with international guidelines, local regulations, and company policies. You'll also manage vendor activities, oversee data collection and cleaning, and potentially conduct site monitoring visits.

Key Responsibilities

1. Oversee vendor activities and participate in study start-up and conduct.
2. Lead investigations into discrepancies in study documentation.
3. Conduct reviews of documentation for internal and external audits.
4. Train site personnel and vendors on study protocols and regulatory requirements.
5. Assess data documentation, reports, and records for consistency and compliance.
6. Verify trial data and ensure proper regulatory documentation is maintained.

Qualifications

1. Bachelor's degree in a relevant field with 5+ years of clinical trial monitoring experience.
2. Medical device experience, with a strong preference for Class III cardiovascular devices.
3. Experience with site- and sponsor-level audits.
4. Excellent communication, presentation, interpersonal, and analytical skills.
5. Experience working with CROs, core labs, and external vendors.
6. Proven problem-solving, critical thinking, and attention to detail.
7. Expertise in MS Office suite and Adobe applications.
8. Experience with Electronic Data Capture Systems (EDC) required.
9. Thorough knowledge of GCP and working knowledge of relevant regulations.
10. Clinical research certification preferred.
11. Up to 50% travel across Europe required.
12. Fluency in English. Fluency in French and German a plus; other EU languages a benefit.

Competitive Benefits Package
Competitive salary, performance-based bonuses, and stock options.
Comprehensive benefits package.
Career development opportunities in a growing and innovative company.

Ready to make a difference?
We are searching for a highly motivated and results-oriented individual to join our team. If you are passionate about advancing healthcare and eager to contribute to a groundbreaking therapy, we encourage you to apply