In-House Clinical Research Regulatory Coordinator

Smith Allergy and Asthma; Munsons Corners (NY); Presencial; USD 30.000 - 41.000; Jornada completa

Descripción de la vacante

The Clinical Research Regulatory Coordinator position at PRACTICE Cortland in Cortland, NY is an in-house role (NOT remote). You will provide centralized regulatory support for start-up, site activation, IRB management, and regulatory quality reviews across multiple clinical research sites.

The ideal candidate has at least 2 years of regulatory experience, strong ICH-GCP knowledge, and proficiency with electronic regulatory systems. Excellent organization and independent work style are essential.

Formación

• Associate's Degree required.
• Minimum 2 years of clinical research regulatory experience required.
• Experience preparing IRB submissions, amendments, and continuing reviews required.
• Experience supporting study start-up and site activation activities preferred.
• Experience working in a multi-study or multi-site environment preferred.

Responsabilidades

• Coordination of study start-up and site activation activities.
• Prepare and submit initial IRB applications and amendments.
• Maintain regulatory timelines and electronic files.
• Support sponsor, CRO, and IRB communications.
• Conduct centralized quality reviews of regulatory documents.

Conocimientos

ICH-GCP knowledge

Organizational skills

Project management

Communication skills

Independent worker

Microsoft Office

Electronic regulatory systems

Educación

Associate's Degree

Herramientas

REALTIME CTMS

eRegulatory modules

REALTIME eRegulatory

Microsoft Office

Descripción del empleo

The Clinical Research Regulatory Coordinator position at PRACTICE Cortland in Cortland, NY is an in-house role (NOT remote). You will provide centralized regulatory support for start-up, site activation, IRB management, and regulatory quality reviews across multiple clinical research sites.

The ideal candidate has at least 2 years of regulatory experience, strong ICH-GCP knowledge, and proficiency with electronic regulatory systems. Excellent organization and independent work style are essential.