Senior Clinical Research Associate – FSP

🔥 2 hours 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

• Manage assigned investigator sites from site activation through database lock • Conduct site management, site monitoring, and close-out activities for assigned clinical trials • Ensure clinical trials comply with monitoring plans, applicable laws, GCP, and client standards • Serve as primary contact for assigned investigator sites and manage site relationships • Coordinate information flow among study team members, vendors, and investigator sites • Coach and train site personnel and provide protocol training • Support site activation, recruitment, enrollment, and investigator meeting activities • 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 TMF documentation, site reports, follow-up letters, protocol deviations, recruitment updates, clinical supply information, study progress, and metrics • Identify and resolve site issues and develop corrective and preventive actions • Resolve data queries and conduct investigator site close-out activities • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support database release and potentially perform unblinded monitoring • Maintain product, protocol, and therapy-area knowledge to support patient safety and clinical guidance • Drive Quality Event remediation and audit observation CAPA activities when applicable • Report to the Director of Clinical Site Operations or Director of Site Management and Monitoring • Partner with Site Care Partners, Country Study Operations Managers, and other study team members • Mentor Clinical Research Associates when required • Complete required training, timesheets, expense reports, and CV updates • Maintain compliance with Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• Minimum 3 years of relevant experience in clinical research site monitoring • Preferably 2 years of experience in Oncology • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Global clinical trial experience • Fluent in English and in the native language(s) of the country they will work in • Significant travel (60-80%) within the area; 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, reporting, and other key operational elements of clinical research • Demonstrated knowledge of disease and technical areas pertaining to clinical studies, investigational products, and associated development plans • Demonstrated ability to support sponsor regulatory interactions and inspections • Demonstrated knowledge of protocol design and feasibility assessment processes • Demonstrated understanding of regional/country culture and medical practice and their effect on clinical trial delivery • Proven ability to work in a matrix team environment and influence, drive/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

🏖️ Benefits

• Equal opportunity employment consideration • Significant travel within the area and some international/weekend travel may be required (job-related compensation/condition, not a benefit)

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