[Remote] Sr. Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is committed to innovation in life sciences, diagnostics, and biotechnology. The Sr. Clinical Research Associate will be responsible for overseeing reputed company, ensuring compliance with FDA standards, and managing relationships with external sites and stakeholders to maintain data reputed company and successful trial execution.

Responsibilities

• reputed company clinical study protocol execution at external sites, from start-up to reputed company-out, ensuring reputed company data collection and compliance with FDA standards and Good Clinical reputed company (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 reputed company 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 reputed company
• Contribute to study planning including budget and contract negotiation and reputed company forecasts, site identification and qualifications, and process improvement initiatives reputed company the Global Clinical Affairs organization; as reputed company 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 0-2 years clinical research experience
• Basic knowledge of regulatory requirements and Good Clinical reputed company 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 reputed company 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
• CLSI guidelines and Good Laboratory reputed company (GLP)

Benefits

• Bonus/incentive pay
• reputed company time off
• Medical/dental/reputed company insurance
• 401(k) to eligible employees
• Remote work arrangement in which you can work remotely from your home

reputed company

Company H1B Sponsorship