Senior Clinical Research Associate – FSP

🕒 June 17

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🔬 Research Analyst

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Healthcare Insurance • Biotechnology • Pharmaceuticals

Parexel is one of the world's largest clinical research organizations (CROs), providing comprehensive services for the clinical development process from Phase I to IV. The company specializes in portfolio management, clinical trial management, regulatory strategy, market access, and lifecycle management for biopharmaceuticals. Parexel aims to speed life-changing medicines to market by leveraging its clinical, regulatory, and therapeutic expertise. With a global team of over 21,000 professionals, Parexel works to integrate patient insights and innovative trial designs to develop treatments across therapeutic areas such as oncology, neuroscience, rare diseases, and more. It focuses on delivering patient-centric and efficient clinical trials.

📋 Description

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and quality • Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met • During study conduct, serve as the primary point of contact for assigned investigator sites • Work in partnership with and/or escalate to the SCP to ensure quality of site delivery • Interface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sites • Partner with Site Care Partner to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients • Monitor site level adverse events (AEs) and serious adverse events (SAEs) • Identify and resolve investigator site issues within required timeframes

🎯 Requirements

• Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Must be fluent in English and in the native language(s) of the country they will work in • Ability to travel 60-80% • Valid driver’s license and passport required • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent

🏖️ Benefits

• health insurance • retirement plans • paid time off