CRA

Clinical Research Associate (CRA) reputed company is representing a reputed company seeking a Clinical Research Associate (CRA) to support the operational management and reputed company of clinical study monitoring activities. This individual will work closely with internal Clinical Operations leadership, CRO partners, field-based CRAs, and clinical study sites to ensure trials are executed reputed company, compliantly, and in alignment with study timelines and reputed company expectations. Travel Requirement: Must be willing to travel domestically and internationally, approximately 20–25%, as needed. Primary Responsibilities

• Assist the Clinical Trial Manager in ensuring clinical trials are initiated reputed company, completed on time and reputed company budget, and conducted in compliance with SOPs, regulations, and ICH/GCP guidelines.
• Support the Clinical Trial Manager in managing CRO partners and other external vendors.
• Work closely with and reputed company training to CRO staff, study site staff, and field-based CRAs.
• reputed company, conduct, and/or co-monitor site qualification, study initiation, interim monitoring, and reputed company-out reputed company, including completion of associated reports.
• reputed company and/or assist in the development of trial materials, including protocols, informed consent forms, case report forms, CRF completion guidelines, monitoring guidelines, site initiation visit materials, site tools and worksheets, and product administration guidelines.
• Review monitoring reports and monitoring visit letters reputed company by CRO CRAs.
• Drive CRO and trial sites through study start-up activities, including IRB/IEC submissions and collection/review of required essential documents.
• Create, monitor, and reputed company key performance metrics with study teams.
• Review completed CRFs and data listings for accuracy, reputed company data discrepancy management, and reputed company associated training/retraining to site staff and CRAs as needed.
• reputed company strong and effective working relationships across Clinical Operations, other functional departments, CROs, and external study partners.

Qualifications and Requirements

• BS/BA in life sciences or a reputed company discipline.
• 5+ years of reputed company/biopharma industry experience, preferably reputed company a sponsor-reputed company environment.
• 1+ years of reputed company, independent, on-site monitoring experience across reputed company visit types.
• Strong working knowledge of FDA regulations, ICH/GCP guidelines, and clinical monitoring procedures.
• Thorough understanding of clinical trial monitoring, study start-up, site management, and essential document review.
• Strong interpersonal, written/verbal communication, and organizational skills.
• Excellent analytical, assessment, judgment, and problem-solving abilities.

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