Site Care Partner – Senior/Lead CRA

🔥 1 hour ago

🇰🇷 South Korea – Remote

⏰ Full Time

🟠 Senior

🪙 Affiliate Manager

👻 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

• Qualify and activate assigned clinical trial sites • Support country and site selection, including site list assessment and site qualification • Provide country/regional input on protocol feasibility, standard of care, and medical practices • Conduct site start-up activities, including site qualification, activation checklist coordination, ICF finalization, and SIV • Coordinate site activation training and required documentation and systems • Complete post-qualification and SIV follow-up to ensure site readiness for FSFV • Partner with CRAs to ensure site monitoring readiness and enrollment delivery • Build and maintain relationships with site organizations, strategic partners, investigators, and site staff • Resolve escalated site delivery issues involving vendors, contracts, and payments • Manage investigational product and ancillary supply strategies throughout the study lifecycle • Support recruitment planning and delivery against global, country, and local targets • Partner with regulatory authorities and study start-up teams to complete country and local registry activities • Provide site recommendations and intelligence on country/region requirements, processes, practices, and site performance • Support import/export requirements for investigational products and ancillary supplies • Review site reports and related issues • Assure quality and consistency in monitoring delivery • Support CRA relationships with investigators and escalate training or compliance concerns • Complete required training, timesheets, expense reports, and CV updates • Comply with Parexel processes, ICH-GCP, and applicable requirements

🎯 Requirements

• At least 8+ years of CRA experience • Oncology study experience • Experience in other therapeutic areas is a plus • Knowledge of Good Clinical Practice/ICH Guidelines and applicable regulatory requirements • Good computer skills and ability to embrace new technologies • Ability to manage required travel • Knowledge of country-specific GCP requirements • Demonstrated experience in site management with prior CRA experience • Demonstrated experience in start-up activities through site activation • Demonstrated experience in conduct and close-out activities • Demonstrated knowledge of quality and regulatory requirements in applicable countries • Bachelor’s degree or RN in a related field, or equivalent combination of education, training and experience (at least 5 years’ experience) • English is required; proficiency in the local language preferred