Clinical Study Regulatory and Data Coordinator

Overview

Join our dynamic team as a Clinical Study Coordinator and play a pivotal role in advancing medical research and patient care. In this energetic and vital position, you will oversee the coordination and management of clinical trials, ensuring adherence to regulatory standards and research protocols. Your proactive approach will facilitate smooth study operations, support patient safety, and uphold the highest quality standards in clinical research. This paid position offers an exciting opportunity to contribute to groundbreaking healthcare developments while working in a collaborative, fast-paced environment.

Responsibilities

• Coordinate all aspects of clinical trial activities, including participant recruitment, scheduling, and follow-up procedures.
• Monitor patient progress throughout the study, ensuring compliance with protocol requirements and safety guidelines.
• Review and verify clinical documentation, including consent forms, case report forms, and medical records for accuracy and completeness.
• Manage data collection processes using electronic medical record (EMR) systems and ensure data integrity according to CDISC standards.
• Ensure compliance with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and other applicable healthcare regulations.
• Supervise research staff and collaborate with multidisciplinary teams to facilitate study progress and quality assurance.
• Prepare detailed reports on study progress, adverse events, and regulatory documentation for review by sponsors and regulatory bodies.

Skills

• Proven supervising experience in clinical research or healthcare settings.
• Strong knowledge of medical terminology, clinical laboratory procedures, and blood sampling techniques.
• Expertise in reviewing clinical documentation and managing data within EMR systems.
• Familiarity with statistical software for data analysis and reporting purposes.
• Comprehensive understanding of FDA regulations, ICH GCP standards, and healthcare compliance requirements.
• Experience with project management tools and methods specific to clinical trials management.
• Excellent communication skills for effective patient monitoring, team collaboration, and regulatory interactions.
• Certification in ICH GCP (Good Clinical Practice) from a recognized issuer is highly desirable.

Embark on a rewarding career that combines scientific rigor with compassionate patient care! We are committed to fostering an inclusive environment where your expertise can thrive as you contribute to meaningful health advancements through innovative clinical research practices.

Pay: $50,526.91 - $80,000.00 per year

Work Location: In person