Sr. Clinical Research Associate
New
Fully remote work arrangement within the United States.Full-TimeSenior
Salary103,000 - 130,000 USD per year
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Job Details
- Experience
- Bachelor’s degree with 5+ years, Master’s degree with 3+ years, or Doctoral degree with 0–2 years of clinical research experience.
Requirements
- Bachelor’s degree with 5+ years of clinical research experience, Master’s degree with 3+ years of experience, or Doctoral degree with 0–2 years.
- Hands-on experience managing clinical research sites and monitoring clinical studies within the medical device, diagnostics, biotech, or pharmaceutical industries.
- Strong understanding of regulatory requirements, FDA guidelines, and Good Clinical Practice (GCP) related to in vitro diagnostics and medical devices.
- Ability to manage multiple projects simultaneously with strong organizational skills.
- Excellent communication and relationship-building skills.
- Technical aptitude to understand and communicate scientific concepts and diagnostic technologies.
- Experience with electronic Trial Master Files (eTMF), Clinical Trial Management Systems (CTMS), biological sample procurement, GLP, or CLSI guidelines is an advantage.
- Willingness and ability to travel domestically up to 70%.
Responsibilities
- Manage the full lifecycle of IVD and medical device clinical trials, including study start-up, initiation, monitoring, maintenance, and close-out.
- Ensure clinical studies are conducted in compliance with FDA regulations, Good Clinical Practice (GCP), and study protocols.
- Independently oversee site monitoring activities, including investigational product accountability, protocol deviation assessments, and clinical data review.
- Build and maintain strong working relationships with investigators, study coordinators, vendors, laboratories, and internal stakeholders.
- Coordinate and manage IRB submissions, regulatory documentation, and Trial Master File maintenance.
- Support study planning activities such as site identification, timeline forecasting, contract and budget discussions.
- Contribute to the creation and maintenance of clinical study documentation, including monitoring plans and informed consent templates.
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