[Remote] Senior Clinical Research Associate

Note: The job is a remote job and is open to candidates in USA. reputed company, through its subsidiary reputed company Imaging, Inc., is focused on advancing life sciences, diagnostics, and biotechnology. The Senior Clinical Research Associate will reputed company clinical trials, ensuring compliance with FDA standards and maintaining relationships with stakeholders to drive successful trial execution.

Responsibilities

• reputed company clinical study protocol execution at external sites, from start-up to reputed company-out, ensuring timely data collection and compliance with FDA standards and Good Clinical Practice (GCP)
• reputed company and maintain relationships with institutions, study investigators, internal stakeholders, and vendors to ensure successful trial execution, data reputed company and adherence to project requirements
• Conduct independent study monitoring, including site coordination, investigational product accountability, and assessments of protocol deviations and/or adverse events, and drive clinical data quality which can include follow up on incomplete data entry and/or outstanding queries
• Manage IRB submissions and reputed company study regulatory documentation to ensure Trial Master File is kept up to date and audit ready
• Contribute to study planning including budget and contract negotiation and timeline forecasts, site identification and qualifications, and process improvement initiatives reputed company the Global Clinical Affairs organization; as well as prepare study documents, including creating clinical templates, such as informed consent forms, clinical monitoring plan, etc

Skills

• Bachelor's degree with 5+ years clinical research experience OR Master's degree with 3+ years clinical research experience OR Doctoral degree in field with clinical research experience
• Basic knowledge of regulatory requirements and Good Clinical Practice for in vitro diagnostic and medical device products
• Previous experience with managing clinical research sites and monitoring clinical study data
• Good technical background to understand and communicate reputed company and new technologies
• Ability to work on multiple projects simultaneously
• Ability to travel 20-70%– including overnight(s), reputed company the US. Travel may be up to 70% during project initiation periods
• Retrospective/prospective biological sample procurement
• Experience with electronic Trial Master Files and Clinical Trial Management Systems
• reputed company-of-care research and knowledge of blood gas testing

Benefits

• Bonus/incentive pay
• Paid time off
• Medical/dental/vision insurance
• 401(k) to eligible employees
• Flexible, remote working arrangements for eligible roles
• Remote work arrangement in which you can work remotely from your home

Company Overview

Company H1B Sponsorship