Jobgether
Sr. Clinical Research Associate
Accountabilities:
- 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.
- 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%).
- 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.
Requirements:
Benefits:
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.
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Jobgether runs the largest remote job platform, effectively linking job seekers with over 200,000 flexible and remote opportunities that match their unique skills and preferences. Our focus is on enhancing the hiring process, ensuring efficiency while prioritizing the candidate experience, particularly in the growing health and wellness sector.
- Founded
- Founded 2020
- Employees
- 11-50 employees
- Industry
- Professional Services
Clinical Research Associate