In-house Clinical Research Associate II – CNS/Neurology

🔥 0 minutes ago

🌲 North Carolina – Remote

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💵 $50k - $99k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

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👻 Ghost score 0%

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Logo of Worldwide Clinical Trials

Worldwide Clinical Trials

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 studies in accordance with GCPs, applicable regulations, and SOPs • Support Clinical Trial Managers and field Clinical Research Associates • Collaborate with project team members across roles and departments to achieve site management deliverables on time • Assist with feasibility questionnaires and CDA collection from potential sites • Coordinate shipment and receipt of study materials • Update and quality-review site documentation for Trial Master File filing • Support Investigator Site File maintenance, TMF reconciliation, and TMF quality control • Conduct pre-study, initiation, interim, remote monitoring, and close-out visits under guidance • Support field CRAs and site staff with investigational product inventory • Maintain communication with sites according to monitoring plans • Review electronic data capture CRFs for completion, logic checks, and compliance • Assist sites with resolving EDC and vendor queries • Pull study reports, maintain trackers, and provide information to CTM for project team or sponsor use • Prepare field CRAs for visits by summarizing action items, protocol deviations, queries, supplies, and training needs • Assist with site staff changes, documentation, training, qualifications, and task delegation • Manage vendor access for site staff • Support prescreening, screening, and recruitment • Assist with Subject Eligibility Review tracking and support the Medical Monitor • Serve as operational point of contact for the trial when applicable • Mentor and train In-house CRA I and II team members • Attend and present updates during study meetings • Perform other assigned duties

🎯 Requirements

• Good oral and written communication skills • Good planning and organizational skills with effective time management • Good interpersonal skills • Ability to work in an organized and methodical manner • Good understanding of clinical research principles and process • Good understanding of FDA and/or EU Directive regulations, ICH Guidelines, and local regulatory requirements; training provided by WCT • Good understanding of standard operating procedures; training provided by Worldwide Clinical Trials • Basic knowledge of Microsoft Office • Familiarity with IVRS and eCRF systems; training provided by Worldwide Clinical Trials • A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy, or other related science • A minimum of two years of clinical research experience (e.g., study coordinator, research nurse, etc.) • Experience in CNS/Neurology

🏖️ Benefits

• Competitive benefits package depending on location • Transparent compensation and pay equity

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