In-house Clinical Research Associate II

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $50k - $99k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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 site-related documentation for Trial Master File filing and review documents for quality • 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 field CRA or CTM/PM guidance • Discuss and assist with investigational product inventory • Maintain regular communication with assigned study sites • Complete remote review of EDC case report forms for completion, logic checks, and data-entry compliance • Assist sites with resolution of EDC and vendor queries • Pull reports from study portals and EDC systems; create or maintain study trackers and provide information to CTMs • Prepare field CRAs for visits by summarizing action items, protocol deviations, queries, supplies, and training needs • Assist with site staff changes, CTMS updates, essential and regulatory document collection, and training review • Manage vendor access for site staff • Support prescreening, screening, and recruitment • Assist with Subject Eligibility Review tracking and support the Medical Monitor • Serve as main operational 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

• A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science AND a minimum of two years of clinical research experience OR one year of IHCRA experience OR other relevant experience • OR two-year college curriculum or equivalent education/training AND a minimum of three years of clinical research experience OR two years of IHCRA experience OR other relevant experience • OR other relevant education/training (example: LPN certification and/or relevant work experience) AND a minimum of four years of clinical research experience may be considered OR two years of IHCRA experience • Fluent in the local languages of the countries under responsibilities • Proficient in both spoken and written English • 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 • Good understanding of standard operating procedures • Basic knowledge of Microsoft Office • Familiarity with IVRS and eCRF systems

🏖️ Benefits

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