Senior Clinical Research Associate
New
C
CoMindMedical Devices
Remote, US, Eastern or Central Time zoneFull-TimeSenior
Salary not disclosed
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Job Details
- Required Skills
- GCP
Requirements
- Substantial clinical research experience
- Background in medical devices preferred
- Extensive on-site and remote monitoring experience as a sponsor-side CRA
- Strong working knowledge of GCP, ICH, FDA, and applicable global clinical research regulations
- Proven organisational and documentation skills
- Proficiency with EDC, eTMF, CTMS, and standard office software
- Experience with early feasibility studies, NSR studies, or IDE-regulated frameworks (Nice to have)
- Familiarity with neurology, neurocritical care, TBI, or ICU-based clinical settings (Nice to have)
Responsibilities
- Conduct qualification, initiation, interim, and close-out monitoring visits (on-site and remote)
- Perform source data review and verification and manage data query resolution
- Evaluate site performance, protocol adherence, and enrollment progress
- Identify and escalate site issues, deviations, and risks
- Support CAPA development and inspection and audit readiness activities
- Build and maintain strong relationships with investigator sites
- Prepare, submit, and track IRB maintenance submissions
- Maintain Trial Master File quality and support regulatory submissions
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