Job Description

Responsibilities

• Manage day-to-day clinical research activities in compliance with SOPs, GCP, ICH, and FDA regulations.
• Prepare and maintain regulatory documents, including IRB submissions and protocol amendments.
• Act as a liaison with sponsors, CROs, monitors, and IRBs.
• Recruit, screen, and consent study participants, ensuring protocol eligibility.
• Conduct and document study visits, data collection, and data entry.
• Handle specimen collection, preparation, and shipment.
• Monitor participant compliance, report adverse events, and maintain investigational product accountability.
• Support monitoring visits, audits, and inspections.
• Assist in staff training on study-specific procedures.

Requirements

• Associate’s or Bachelor’s degree in Nursing, Health Sciences, or related field.
• 2+ years of clinical research or healthcare experience.
• Knowledge of clinical trial protocols, GCP, and regulatory processes.
• Strong organizational, communication, and interpersonal skills.
• Proficiency with Microsoft Office and electronic data capture systems.

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