Senior Clinical Research Coordinator

Job Description

Job Description

Job Overview
We are seeking a highly motivated and experienced Senior Clinical Research Coordinator to join our dynamic research team. In this pivotal role, you will oversee the planning, execution, and management of clinical trials, ensuring compliance with regulatory standards and ethical guidelines. Your expertise will drive the successful delivery of research projects that advance medical knowledge and patient care. This position offers an exciting opportunity to lead complex studies within a collaborative environment dedicated to innovation and excellence in clinical research.

Duties

• Lead and supervise clinical research teams, providing guidance on study protocols, regulatory compliance, and data collection procedures
• Coordinate all aspects of clinical trials, including patient recruitment, screening, enrollment, and monitoring to ensure adherence to study protocols
• Review and verify clinical documentation for accuracy, completeness, and regulatory compliance in accordance with FDA regulations and ICH GCP standards
• Oversee patient monitoring activities such as blood sampling, vital signs assessment, and adverse event reporting to ensure participant safety
• Manage data collection processes using EMR (Electronic Medical Records) systems and ensure data integrity aligned with CDISC standards
• Conduct site visits for quality assurance audits and implement corrective actions as needed to maintain high standards of clinical trial conduct
• Collaborate with cross-functional teams on project management tasks including timelines, resource allocation, and progress reporting while ensuring compliance with healthcare regulations like HIPAA
• Maintain up-to-date knowledge of clinical laboratory procedures, statistical software tools, and healthcare compliance requirements to support research integrity

Experience

• Proven supervising experience in a clinical research setting or healthcare environment with a strong understanding of clinical trials management
• Extensive knowledge of medical terminology, FDA regulations, ICH GCP guidelines, and clinical ethical standards governing human subjects research
• Demonstrated proficiency in documentation review, data management systems, EMR platforms, and statistical software used in clinical analysis
• Hands-on experience with blood sampling techniques, clinical laboratory procedures, and analysis skills relevant to trial activities
• Strong project management skills with a track record of coordinating multiple research projects simultaneously within strict timelines
• Certification in ICH GCP (Good Clinical Practice) from a recognized issuer is required; additional certifications such as HIPAA training or project management credentials are advantageous
• Familiarity with clinical research methods including protocol development, compliance management, quality assurance standards, and research ethics guidelines

Join us to make a meaningful impact through innovative clinical research! We value dedicated professionals who thrive in collaborative environments while upholding the highest standards of scientific integrity. This role offers an engaging opportunity for those passionate about advancing healthcare through meticulous study coordination and leadership.

Diverse team of researchers dedicated to advancement of research in mental health.

Company Description

Diverse team of researchers dedicated to advancement of research in mental health.