FULL-TIME
Posted Oct 2, 2026
Job Description
Role Overview: The Senior CRA is responsible for leading site monitoring and study oversight in clinical programs, ensuring compliance with GCP, ICH, and FDA regulations.
Key Responsibilities: Conduct qualification, initiation, interim, and close-out visits (both on-site and remote); review and verify source data; manage data queries; evaluate site performance; identify and escalate issues; support CAPA development; build strong investigator relationships; handle IRB submissions and maintenance; maintain Trial Master Files; support regulatory activities and IP logistics.
Qualifications & Skills: Extensive clinical research experience, preferably in medical devices; strong on-site and remote monitoring background; knowledge of GCP, ICH, FDA regulations; excellent organization and documentation skills; proficiency with EDC, eTMF, CTMS, and office software.
Preferred Experience: Early feasibility or IDE studies; neurology or neurocritical care settings; IRB coordination.
Additional Attributes: Embrace AI as part of work culture, strong relationship management, and ability to handle multiple responsibilities.
Benefits: Equity, unlimited PTO, health, dental, vision insurance, 401k with match, and mental health resources.
Key Responsibilities: Conduct qualification, initiation, interim, and close-out visits (both on-site and remote); review and verify source data; manage data queries; evaluate site performance; identify and escalate issues; support CAPA development; build strong investigator relationships; handle IRB submissions and maintenance; maintain Trial Master Files; support regulatory activities and IP logistics.
Qualifications & Skills: Extensive clinical research experience, preferably in medical devices; strong on-site and remote monitoring background; knowledge of GCP, ICH, FDA regulations; excellent organization and documentation skills; proficiency with EDC, eTMF, CTMS, and office software.
Preferred Experience: Early feasibility or IDE studies; neurology or neurocritical care settings; IRB coordination.
Additional Attributes: Embrace AI as part of work culture, strong relationship management, and ability to handle multiple responsibilities.
Benefits: Equity, unlimited PTO, health, dental, vision insurance, 401k with match, and mental health resources.
Benefits
- Dental insurance
- Paid time off
- Health insurance
Additional Details
- City
- Missouri City
- State
- Missouri
- Country
- US
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