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.

• 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.

• 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