Clinical Research Associate – FSP

🔥 18 minutes ago

🇰🇷 South Korea – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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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 and escalate issues to the SCP as needed • Facilitate information flow among study team members, vendors, and investigator sites • Perform investigator site development, coaching, training, and protocol training • Attend investigator meetings and support enrollment, site activation, 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 TMF documentation, site reports, follow-up letters, protocol deviations, recruitment, clinical supply, study progress, and metrics updates • 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 serve as an unblinded monitor when appropriate • Maintain product, protocol, and therapy-area knowledge and support patient safety and eligibility • Drive Quality Event remediation and audit observation CAPA activities when applicable • Partner with SCP, Country Study Operations Manager, clinicians, recruitment specialists, and clinical data scientists • Mentor/train Clinical Research Associates and Sr CRA I as assigned • Comply with required training, timesheets, expense reports, CV updates, Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• Minimum 3 years relevant experience in clinical research site monitoring • Extensive knowledge of clinical trial methodologies, ICH/GCP and local country regulations • Preferred therapeutic experience in Oncology (Mandatory), Vaccines, Internal Medicine or Infectious Diseases • Global clinical trial experience • Fluent in English and in the native language(s) of the country they will work in • Significant travel is 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 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/inspections • Demonstrated knowledge of protocol design and feasibility assessment processes • Demonstrated understanding of regional/country culture and medical practice and their impact on clinical trial delivery • Proven ability to work in a matrix team environment and influence, drive/lead, and work through others for successful clinical trial delivery • 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