Clinical Research Assistant

Support the clinical research team across subject recruitment, informed consent, study coordination, data collection, regulatory compliance, and sponsor communications to keep trials running smoothly from start-up to close-out. Key Duties & Responsibilities Identify potential research participants through medical records and physician referrals. Conduct pre-screening interviews and determine study eligibility based on protocol requirements. Schedule study visits and maintain ongoing participant communication. Explain study procedures, risks, benefits, and participant responsibilities, and conduct informed consent discussions. Maintain participant engagement, safety, and confidentiality throughout the study. Coordinate protocol-required study visits and collect source data, medical histories, vital signs, and study-related information. Maintain accurate source documentation and ensure protocol compliance. Maintain regulatory binders and essential study documents. Enter and review study data in Electronic Data Capture (EDC) systems and resolve data queries. Ensure compliance with FDA, ICH-GCP, IRB, and sponsor requirements. Coordinate monitoring visits, audits, and sponsor communications; assist investigators with study reports and documentation. Participate in study start-up, training, and close-out activities. Requirements Bachelor's Degree in Life Science, Applied Life Science, or Public Health Strong attention to detail and documentation skills Excellent interpersonal and communication skills Familiarity with FDA, ICH-GCP, and IRB requirements preferred #J-18808-Ljbffr