Senior Clinical Research Associate
$103,000–$130,000 year
Remote · United States
Job Summary
Senior Clinical Research Associate (Sr. CRA) oversees set-up, initiation, execution, monitoring and close-out of IVD and medical device clinical trials at external sites and/or laboratories. Manages external sites, regulatory documentation (IRB/Trial Master File), protocol execution, data integrity, and monitoring, with responsibilities including site coordination, investigational product accountability, and handling deviations/adverse events. Involves budget/contract planning, feasibility, site qualification, template creation (e.g., informed consent form, monitoring plan), and ensuring compliance with FDA standards and GCP. Requires ability to travel; experience with regulatory submissions, TMF/CTMS systems, and remote trial management within a global clinical affairs context; supports flexible remote work within the US. Expect 20-70% travel; remote work arrangement described for eligible roles.
Required Qualifications
- Bachelor’s degree in a life sciences/related field with 5+ years clinical research experience OR Master’s degree with 3+ years OR Doctoral degree with clinical research experience
- Basic knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products
- Experience managing clinical research sites and monitoring study data
- Ability to work on multiple projects concurrently
- Travel ability: 20-70% within the US (up to 70% during initiation)
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