Sr. Clinical Research Associate in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Sr. Clinical Research Associate in United States.

This is an exciting opportunity for an experienced clinical research professional to contribute to the advancement of innovative diagnostic and medical device technologies that improve patient outcomes worldwide. In this fully remote role, you will oversee clinical trial operations from study start-up through close-out, ensuring compliance, data integrity, and operational excellence across multiple research sites. You’ll collaborate with cross-functional teams, external investigators, laboratories, and vendors in a fast-paced, science-driven environment focused on precision diagnostics and healthcare innovation. The role offers strong exposure to cutting-edge clinical development programs, meaningful ownership of site management activities, and the flexibility to work remotely while traveling to support critical trial milestones. This position is ideal for someone who thrives in dynamic environments, enjoys building relationships with research partners, and is passionate about driving high-quality clinical execution that directly impacts patient care and scientific progress.

• Manage the full lifecycle of IVD and medical device clinical trials, including study start-up, initiation, monitoring, maintenance, and close-out activities across external clinical sites and laboratories.
• Ensure clinical studies are conducted in compliance with FDA regulations, Good Clinical Practice (GCP), study protocols, and applicable quality standards.
• Independently oversee site monitoring activities, including investigational product accountability, protocol deviation assessments, adverse event follow-up, and clinical data review to maintain data quality and integrity.
• Build and maintain strong working relationships with investigators, study coordinators, vendors, laboratories, and internal stakeholders to support efficient study execution and issue resolution.
• Coordinate and manage IRB submissions, regulatory documentation, and Trial Master File maintenance to ensure inspection readiness and regulatory compliance.
• Support study planning activities such as site identification and qualification, timeline forecasting, contract and budget discussions, and process improvement initiatives within the clinical operations function.
• Contribute to the creation and maintenance of clinical study documentation, including monitoring plans, informed consent templates, and operational procedures.

• 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 of clinical research experience.
• 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 while maintaining strong organizational skills and attention to detail.
• Excellent communication and relationship-building skills, with the ability to collaborate effectively across internal and external teams.
• Technical aptitude to understand and communicate scientific concepts, diagnostic technologies, and clinical processes effectively.
• Experience with electronic Trial Master Files (eTMF), Clinical Trial Management Systems (CTMS), biological sample procurement, GLP, or CLSI guidelines is considered a strong advantage.
• Willingness and ability to travel domestically up to 70%, including overnight travel during critical study phases.

• Competitive salary ranging from $103,000 to $130,000 annually.
• Eligibility for performance-based bonus and incentive compensation programs.
• Fully remote work arrangement within the United States.
• Comprehensive medical, dental, and vision insurance coverage.
• 401(k) retirement savings plan with company-supported benefits.
• Generous paid time off and work-life balance support.
• Opportunity to work on cutting-edge diagnostic technologies with global healthcare impact.
• Collaborative and innovation-focused work environment with strong career development opportunities.