Senior Clinical Research Associate – FSP

🔥 0 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 • Ensure clinical trials comply with the Study Monitoring Plan, applicable laws, GCP, and client standards • Serve as primary contact for assigned investigator sites during study conduct • Manage investigator site relationships and facilitate information flow among study teams, vendors, and sites • Partner with the Site Care Partner to develop, coach, and train site personnel • Provide protocol training and address protocol-related questions and risks • Attend investigator meetings and support site 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, documentation, tracking, and Trial Master File materials • 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 • Collaborate with the DCSO/DSMM, SCP, Country Study Operations Manager, clinicians, recruitment specialists, and clinical data scientists • 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 • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious Diseases • Global clinical trial experience • Fluent in English and the native language(s) of the country they will work in • Significant travel (60-80%) within area; some international and weekend travel may be required • Valid driver’s license and passport required • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local country regulations • Knowledge of clinical research and development processes • Knowledge of global and local regulatory requirements • Understanding of monitoring, data acquisition and cleaning, reporting, and other operational elements • Knowledge of disease and technical areas pertaining 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, drive/lead, and work 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 professional degree in life sciences such as nursing, pharmacy, medical background, or equivalent

🏖️ Benefits

• Equal opportunity employer • Significant travel (60-80%) within area is required; some international and weekend travel may be required