Senior Clinical Research Coordinator

Manhattan Research; New York (NY); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Manhattan Research is seeking a Senior Clinical Research Coordinator to oversee planning, execution, and management of clinical trials, ensuring regulatory compliance and ethical guidelines. This role leads study teams and manages patient recruitment, data integrity, EMR use, and CDISC standards.

The position requires collaboration across functions in a dynamic environment focused on innovation and excellence in clinical research, advancing medical knowledge and patient care.

Qualifications

• Experience supervising clinical research teams.
• Strong knowledge of FDA regulations and ICH GCP.
• Proficiency in data management and trial documentation.
• Experience with blood sampling and laboratory procedures.
• Excellent project management and coordination skills.

Responsabilités

• 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

Connaissances

Project management

Clinical trial supervision

Regulatory compliance

Data management

EMR systems

CDISC standards

Blood sampling

Outils

EMR systems

Statistical software

CDISC data standards

Description du poste

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

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

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.

Company Description

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

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