Clinical Research Associate

Overview

This role entails performing clinical study start-up activities and comprehensive study execution adhering to regulatory guidelines. The associate will be chiefly responsible for review of informed consent forms (ICF), generating study-specific essential document checklists, tracking study progress, and maintaining effective communication about study activities.

Qualifications and Experience

• Bachelor's degree or equivalent qualification in a relevant field.
• 2 to 4 years of experience in clinical research.
• Sound clinical background with familiarity in clinical study processes, monitoring techniques, Good Clinical Practice (GCP), and applicable regulations.
• Strong commitment to compliance and safeguarding the rights and welfare of human subjects involved in clinical studies.

Key Responsibilities

• Execute study start-up procedures including ICF review conforming to regulatory standards.
• Create and maintain tailored essential document listings specific to each study.
• Monitor and communicate study progress and activities effectively.
• Detect and analyze discrepancies in study documentation leveraging clinical protocol and GCP knowledge.
• Develop and implement corrective measures to prevent recurrence of documentation issues throughout the study phases.
• Perform internal and site-based document reviews and contribute to audits by regulatory bodies such as FDA, DEKRA, PMDA ensuring compliance with Good Documentation Practices and relevant internal SOPs.
• Continuously evaluate existing workflows to identify areas for improvement and offer solutions to optimize efficiency within clinical research functions.
• Collaborate with cross-functional teams including clinical data management and field teams to manage queries and review data for resolution.