Clinical Research Assistant

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🕒 5 days ago

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ALLEN SPOLDEN

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

Biotechnology • Healthcare Insurance • Pharmaceuticals

ALLEN SPOLDEN is a workforce solutions provider specializing in talent and research solutions for the pharmaceutical, biotech, healthcare, and public health sectors. They offer services including functional service provider (FSP) solutions, data management, regulatory affairs guidance, and tailored staffing services to meet the specific needs of clinical research projects. Their expertise is aimed at driving efficiency, enhancing productivity, and ensuring compliance throughout clinical trial operations.

📋 Description

• Support the coordination and administration of clinical research studies while ensuring study documentation, data quality, and regulatory compliance are maintained throughout the research process. • Assist with the day-to-day management of assigned clinical studies. • Maintain investigator site files, regulatory binders, and essential study documents. • Prepare, review, and file research documentation in accordance with study requirements. • Support participant scheduling and study visit coordination. • Enter, verify, and reconcile clinical data within electronic research systems. • Monitor study timelines and assist with tracking project deliverables. • Communicate effectively with investigators, sponsors, study participants, and internal research teams. • Identify and escalate documentation discrepancies or protocol deviations when appropriate. • Ensure research activities are conducted in compliance with ICH Good Clinical Practice (GCP), study protocols, and applicable regulatory requirements. • Perform additional administrative and research support duties as assigned.

🎯 Requirements

• Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related discipline, or equivalent healthcare experience. • Strong organizational and problem-solving abilities. • Excellent verbal and written communication skills. • High level of accuracy and attention to detail. • Proficiency with Microsoft Office and web-based software applications. • Ability to manage multiple priorities while working independently in a remote setting. • Previous experience supporting clinical research or healthcare operations preferred. • Familiarity with ICH-GCP guidelines and FDA regulations preferred. • Experience using Electronic Data Capture (EDC), CTMS, or eTMF systems preferred. • Knowledge of clinical trial documentation and research workflows preferred.

🏖️ Benefits

• Competitive salary • Comprehensive medical, dental, and vision coverage • 401(k) with employer contribution • Paid time off and company holidays • Remote work environment • Professional development and career advancement opportunities