Clinical Research Associate II

Recruiter Summary of Position:

• Job Title: Clinical Research Associate II (Medical Device)
• Location: Remote (Dallas-Fort Worth Area)
• Work Arrangement: 1099 Consulting (Remote with 30–50% Travel)

Required Skills:

• 3–5 years of Medical Device clinical monitoring.
• Proficiency in FDA regulations (IDE/510k) and ICH guidelines. Experience with full-cycle study conduct (selection through close-out).

Preferred Skills:

• CRA Certification (CCRA via SOCRA or ACRP).
• Neurology therapeutic experience.

Employer Value Proposition: Join a well-funded startup in a high-impact role. Influence product readiness through direct collaboration with R&D and Regulatory Affairs while enjoying the autonomy of a remote, flexible consulting arrangement.

Job Description:

As a Clinical Research Associate with the company, you are the guardian of data integrity for life-changing medical technology. You aren't just a monitor; you are the eyes and ears of a specialized clinical program. You’ll spend your days building vital relationships with investigators, ensuring every data point is bulletproof, and collaborating directly with R&D and Regulatory teams to move innovative neurology devices from the lab to the patients who need them most.

Why This Role is Different:

• Total Project Ownership: Manage the full study lifecycle—from site selection to close-out—within a high-visibility startup environment.
• Strategic Impact: Influence the company’s future by contributing directly to IDE and 510(k) regulatory submissions.
• True Autonomy: Manage your own travel schedule and remote workspace while overseeing a well-funded clinical program.

Your Mission: You will ensure every facet of our studies meets the highest standards of quality. Your focus is on the "big picture" of study success:

• Site Management: Drive day-to-day execution and conduct visits to ensure protocol adherence and patient safety.
• Data Integrity: Meticulously review source documentation and CRFs to ensure every data point is audit-ready.
• Collaboration: Act as the vital link between external investigators and our internal R&D and Regulatory departments.

Qualifications: We are looking for a professional with a Bachelor’s degree in a scientific field, 3–5 years of medical device monitoring experience, and a deep understanding of FDA/ICH guidelines. If you are a highly organized communicator ready for 30–50% travel, we want to hear from you.

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