Sr. Clinical Research Associate

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Sr. Clinical Research Associate based in United States.

This role plays a key part in advancing clinical research for in vitro diagnostics and medical devices that directly contribute to improving patient outcomes worldwide. You will oversee the full lifecycle of clinical studies, from site initiation to close-out, ensuring compliance with regulatory standards and Good Clinical Practice guidelines. Acting as a critical link between research sites, investigators, and internal teams, you will help ensure data integrity, study quality, and operational excellence across multiple trials. The position is fully remote within the United States, with significant travel to clinical sites as needed. You will work closely with cross-functional stakeholders in a fast-paced global clinical affairs environment. This is an opportunity to contribute to innovative diagnostic solutions that accelerate scientific progress and improve healthcare delivery at scale.

• Manage the end-to-end execution of clinical trials for in vitro diagnostics and medical devices, including start-up, monitoring, and close-out activities across external sites and laboratories.
• Conduct independent site monitoring visits to ensure protocol adherence, data accuracy, investigational product accountability, and compliance with FDA regulations and Good Clinical Practice standards.
• Coordinate and maintain regulatory documentation, including IRB submissions, Trial Master File updates, and study essential documents to ensure audit readiness.
• Develop and maintain strong relationships with investigators, clinical sites, vendors, and internal stakeholders to support successful study execution and data quality.
• Support study planning activities such as site selection, feasibility assessments, budgeting, contracts, and timeline forecasting.
• Identify and resolve study-related issues, including protocol deviations, data queries, and incomplete documentation, to ensure high-quality clinical outcomes.

Requirements:

• Bachelor’s degree with 5+ years of clinical research experience, or Master’s degree with 3+ years, or Doctoral degree with 0–2 years of relevant experience.
• Strong understanding of Good Clinical Practice (GCP), FDA regulations, and clinical trial processes for medical devices or in vitro diagnostics.
• Proven experience in clinical site monitoring, study coordination, and managing external research sites.
• Ability to manage multiple studies simultaneously in a fast-paced, deadline-driven environment.
• Strong communication and relationship-building skills with investigators, vendors, and cross-functional teams.
• Experience with regulatory submissions, Trial Master File systems, and clinical trial management systems is highly preferred.
• Willingness and ability to travel extensively within the United States (approximately 20–70%).

Benefits:

• Competitive base salary with eligibility for bonus or incentive compensation.
• Comprehensive medical, dental, and vision insurance coverage.
• 401(k) retirement savings plan.
• Paid time off, holidays, and flexible remote work arrangements.
• Employee assistance and mental health support programs.
• Career development opportunities within a global life sciences organization.
• Exposure to cutting-edge diagnostic innovation and impactful clinical research programs.