Senior Clinical Research Associate – FSP

🔥 11 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

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Parexel

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1983

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 Venture Round on 1990-01

Consulting • Healthcare • Logistics

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 according to the Study Monitoring Plan, applicable laws, GCP, and client standards • Manage clinical trial activities at assigned investigator sites from site activation through database lock • Serve as primary point of contact for assigned investigator sites • Facilitate information flow among study team members, vendors, and investigator sites • Perform site development, coaching, and training with the SCP • Provide protocol training and address site staff questions • Attend investigator meetings and support enrollment and recruitment initiatives • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and site closure • Monitor adverse events and serious adverse events and collaborate with the Drug Safety Unit • Submit required reports, TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management, study progress, and metrics • Maintain product, protocol, and therapy-area knowledge • Support patient safety, eligibility, and clinical guidance to investigators • Drive quality-event remediation and audit CAPA activities when applicable • Partner with SCP, Country Study Operations Manager, and other study team members • Report to the Director of Clinical Site Operations or Director of Site Management and Monitoring • May mentor Clinical Research Associates • Complete required training, timesheets, expense reports, and CV updates • Comply with Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology) • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Global clinical trial experience • Must be fluent in English and in the native language(s) of the country they will work in • Significant travel (60-80%) within area is required; some international and weekend travel may be required • Valid driver’s license and passport required • Demonstrated knowledge of clinical research and development processes • Demonstrated knowledge of global and local regulatory requirements • Demonstrated understanding of monitoring, data acquisition and cleaning, and reporting • Demonstrated knowledge of disease and technical areas related to clinical studies • Ability to support sponsor regulatory interactions/inspections • Knowledge of protocol design and feasibility assessment • Understanding of regional/country culture and medical practice • Ability to work in a matrix team environment and influence, lead, and work through others • Ability to evaluate, interpret, and present complex issues and data for risk management and mitigation • Effective verbal and written communication skills • Bachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background, or equivalent

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