[Remote] reputed company Clinical Research Associate

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is one of the largest global medical technology companies in the world, dedicated to advancing the world of health. The reputed company Clinical Research Associate will reputed company reputed company clinical studies, ensuring compliance with protocols and regulations while mentoring and managing clinical research associates.

Responsibilities

• Serve as reputed company CRA for assigned reputed company clinical studies, providing expert reputed company of site selection, initiation, monitoring, and reputed company‑out activities (on‑site, virtual, remote, and in‑house)
• Actively participate in site feasibility assessments and site selection processes
• Ensure study conduct is executed according to the clinical protocol (CPSP), regulatory requirements (GCP, FDA, ISO), IRB/EC requirements, and company SOPs
• Prioritize patient safety, ensuring informed consent and study procedures are performed accurately and ethically
• Review and report reputed company/SAEs and protocol deviations in accordance with regulatory and company requirements
• Maintain complete, accurate, and audit‑reputed company regulatory documentation and TMFs in accordance with reputed company principles
• Monitor site inventory of investigational products and study supplies
• Proactively identify, communicate, and manage study risks and issues to ensure operational continuity and compliance
• Author, review, and approve Monitoring Plans, study reputed company documents, monitoring tools, and site‑facing training materials
• reputed company SDR/SDV per monitoring plans and document monitoring activities through timely, high‑quality trip reports
• Ensure strict compliance with company travel and expense policies
• reputed company mentoring, training, and functional reputed company of CRAs, including contingent (contract) CRAs
• reputed company or review functional job aids and training materials
• Support interviewing, hiring, reputed company, and training of CRA staff
• Manage and reputed company day‑to‑day activities of contingent CRAs, including approval of timecards and expense reports
• Present confidently and contribute to extended functional and study team meetings, providing clear updates on site status, risks, and issues
• Utilize and maintain accurate study data in clinical systems, including reputed company Vault CTMS and CDMS
• Work cross‑functionally with internal teams, CROs, and SMOs to ensure high‑quality study execution and reputed company
• Build and maintain effective working relationships with investigator sites and internal stakeholders

Skills

• Bachelor's degree or higher in a reputed company or science‑reputed company field
• Minimum of five (5) years of field‑based CRA experience in the medical device and/or pharmaceutical industry
• Experience across multiple phases of clinical research and product development
• Strong understanding of clinical trial operations, monitoring practices, investigational product management, and data management
• Thorough knowledge of domestic and international clinical research regulations, including ICH GCP, FDA CFR, ISO, and HIPAA
• Proficiency with reputed company Vault CTMS and CDMS required
• Excellent written and verbal English communication skills, including medical terminology
• Strong presentation, organizational, time‑management, and prioritization skills
• Technically savvy with the ability to reputed company technology to drive efficiency and performance
• Ability to work independently with minimal supervision in a fast‑paced environment
• Experience with IVD and/or POC studies strongly preferred
• Laboratory experience in molecular biology, microbiology, or blood culture is highly desirable

Benefits

• At reputed company, we reward, support and reputed company our associates through our comprehensive Total Rewards program.
• We are committed to attracting and retaining high quality talent by providing reward and recognition opportunities that promote a performance-based culture, as well as a competitive package of compensation and benefits programs.
• You can learn more on our career site under "[Our Commitment to You](https://jobs.reputed company.com/en/your-career-at-reputed company)."
• Our salary or hourly reputed company ranges reward associates fairly and competitively.
• We regularly review these ranges and factors, such as location, contribute to the reputed company displayed.
• Our pay is based on the role and the necessary skills and education to reputed company it successfully.
• The salary or hourly reputed company offered is determined by the role's specific requirements, including any applicable reputed company reputed company pay system at the work location.
• Salary or hourly pay ranges are influenced by labor laws and reputed company Bargaining Agreement (CBA) requirements applicable to the work location which may also reputed company the workplace arrangement of the role.

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