Senior Clinical Research Associate – Oncology, FSP

🔥 0 minutes ago

🌲 Oregon, Washington – Remote

🌲 Oregon – Remote ☕ Washington – 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 site management, monitoring, and close-out of assigned investigator sites • Ensure clinical trials follow monitoring plans, applicable laws, GCP, and sponsor standards • Manage trial activities from site activation through database lock • Serve as primary contact for assigned investigator sites • Facilitate information flow among study teams, vendors, and sites • Coach and train site personnel and provide protocol training • Support enrollment and site-level recruitment initiatives • Conduct onsite and remote/electronic monitoring for site initiation, routine monitoring, and closure • Monitor adverse events and serious adverse events and follow up with investigators • Submit Trial Master File documentation, site reports, follow-up letters, protocol deviations, recruitment updates, supply management, progress, and metrics • Identify and resolve site issues and develop corrective and preventive actions • Resolve data queries and conduct site close-out activities • Oversee investigational product receipt, handling, accounting, storage, and destruction • Support database release and undertake unblinded monitoring responsibilities when appropriate • Maintain product, protocol, and therapy-area knowledge • Support patient safety, eligibility, and clinical guidance • Drive Quality Event remediation and audit CAPA activities when applicable • Partner with Site Care Partners, Country Study Operations Managers, clinicians, recruitment specialists, and clinical data scientists • May mentor Clinical Research Associates

🎯 Requirements

• Minimum 3 years of relevant experience in clinical research site monitoring • Preferably 2 years of oncology experience • Clinical research experience in a CRO or pharmaceutical organization • Global clinical trial experience preferred • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations • Fluent in English and the native language(s) of the country of work • Valid driver’s license and passport required • Knowledge of clinical research and development processes • Knowledge of global and local regulatory requirements • Understanding of monitoring, data acquisition and cleaning, and reporting • Knowledge of disease and technical areas related to clinical studies • Ability to support sponsor regulatory interactions and 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 or lead through others • Ability to evaluate, interpret, and present complex issues and data • Effective verbal and written communication skills • Bachelor’s degree in life sciences or required professional life sciences degree such as nursing, pharmacy, or medicine

🏖️ Benefits

• Equal opportunity employer • Global clinical research organization environment • Opportunity to contribute to therapies benefiting patients • Collaboration with global clinical, regulatory, therapeutic, and consulting professionals