Sr. Clinical Research Associate
New
Based in United StatesFull-TimeSenior
SalaryCompetitive base salary with eligibility for bonus or incentive compensation.
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Job Details
- Experience
- Bachelor’s degree with 5+ years of clinical research experience, or Master’s degree with 3+ years, or Doctoral degree with 0–2 years
- Required Skills
- GCP
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%).
Responsibilities
- 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.
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