In-house Clinical Research Associate II

🔥 1 minute ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $50k - $99k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔬 Research Analyst

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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

• Assist with feasibility questionnaires and CDA collection from potential sites • Coordinate study material shipment and receipt by study sites • Update and quality-review site documentation for Trial Master File filing • Support field CRAs with Investigator Site File maintenance, TMF reconciliation, and quality-control checklists • Conduct pre-study, study initiation, interim, remote monitoring, and close-out visits under guidance • Support investigational product inventory discussions with field CRAs and site staff • Maintain regular communication with assigned study sites • Review electronic data capture CRFs for completion, logic checks, and data-entry compliance • Assist sites with resolving EDC and vendor queries • Pull reports, maintain study trackers, and provide information to CTMs and project teams • Prepare field CRA visit-support summaries covering action items, protocol deviations, queries, supplies, and training • Support site staff changes, regulatory documentation, training, qualifications, and task delegation updates • Manage vendor system access for site staff • Support prescreening, screening, and recruitment • Track subject eligibility reviews and support the Medical Monitor • Serve as operational point of contact for clinical research trials when applicable • Mentor and train In-house CRA I and II team members • Attend and present updates during study meetings • Perform other duties as assigned

🎯 Requirements

• Good oral and written communication skills • Good planning, organizational, interpersonal, and time-management skills • Ability to work in an organized and methodical manner • Good understanding of clinical research principles and processes • Good understanding of FDA and/or EU Directive regulations, ICH Guidelines, and applicable local requirements • Good understanding of standard operating procedures • Basic knowledge of Microsoft Office • Familiarity with IVRS and eCRF systems • Four-year college curriculum in medical, biological, physical, health, pharmacy, or related science plus at least two years of clinical research experience, or one year of IHCRA experience, or other relevant experience • Alternatively, two-year college curriculum or equivalent education/training plus at least three years of clinical research experience, or two years of IHCRA experience, or other relevant experience • Other relevant education/training, such as LPN certification, plus at least four years of clinical research experience may be considered, or two years of IHCRA experience • Fluent in the local languages of the countries under responsibility • Proficient in spoken and written English

🏖️ Benefits

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