Clinical Research Associate

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We are seeking a detail-oriented and proactive Clinical Research Associate to support the planning, execution, and monitoring of clinical trials. This role ensures compliance with regulatory requirements and company standards while contributing to high-quality data collection and study integrity.

Key Responsibilities:

• Review and provide input on clinical study protocols, informed consent forms, and clinical study reports.
• Conduct site qualification, initiation, monitoring, and close-out visits in compliance with GCP, regulatory requirements, and SOPs.
• Collaborate with cross-functional teams (Data Management, Regulatory Affairs, and Clinical Operations) to develop data collection tools and ensure accurate data capture.
• Track and manage study documentation, including regulatory binders, site files, and ethics submissions.
• Ensure timely collection and review of essential documents and compliance with regulatory timelines.
• Identify and resolve site issues and protocol deviations, escalating as necessary.
• Assist in organizing investigator meetings and contribute to training materials and site support documentation.
• Maintain up-to-date knowledge of therapeutic areas, regulatory guidelines, and clinical trial processes.

Qualifications:

• Bachelor’s degree in a life science or healthcare-related field; advanced degree preferred.
• Minimum of 2 years of experience in clinical trial monitoring or clinical operations.
• Strong understanding of ICH-GCP guidelines and regulatory requirements.
• Excellent communication, organizational, and problem-solving skills.
• Ability to travel as needed to support clinical trial sites

• Seniority level Associate

• Employment type
  
  Contract

• Job function Research
• Industries Pharmaceutical Manufacturing

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Medical insurance

Vision insurance

401(k)

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