In-House Clinical Research Associate II

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Perform site management tasks for clinical studies according to GCPs, regulations, and SOPs • Support Clinical Trial Managers and field Clinical Research Associates • Assist with site feasibility questionnaires and CDA collection • Coordinate shipment and receipt of study materials • Update and review site documentation for Trial Master File submission • Support Investigator Site File maintenance, TMF reconciliation, and quality-control checklists • Conduct pre-study, initiation, interim, remote monitoring, and close-out visits under guidance • Maintain communication with clinical study sites • Review EDC case report forms for completion, logic checks, and data-entry compliance • Assist sites with EDC and vendor query resolution • Generate portal and EDC reports and maintain study trackers • Prepare field CRA visit materials and summarize action items, protocol deviations, queries, supplies, and training • Support site staff changes, essential-document collection, regulatory documents, training, and task delegation • Manage vendor system access for site staff • Support prescreening, screening, and recruitment • Track subject eligibility reviews and support the Medical Monitor

🎯 Requirements

• Good oral and written communication skills • Good planning, organizational, interpersonal, and time-management skills • Ability to work in an organized and methodical manner • Basic understanding of clinical research principles and processes • Understanding of FDA and/or EU regulations, ICH Guidelines, and local regulatory requirements • Understanding of standard operating procedures • Basic knowledge of Microsoft Office • Familiarity with IVRS and eCRF systems • Two-year college curriculum or equivalent education/training and one year of clinical research or relevant experience • Alternatively, relevant education/training and a minimum of two years of clinical research experience may be considered • Fluent in local languages of countries under responsibility • Proficient in spoken and written English

🏖️ Benefits

• Diverse and inclusive work environment • Supportive and cohesive teams • Accessible leadership • Equal employment opportunities • Exceptional employee experiences • Professional growth and opportunity to succeed