The Clinical Research Support Office (CRSO) is seeking a full-time Regulatory Coordinator. The Clinical Research Support Office (CRSO) is the central office for clinical research support services at CHOP. The CRSO provides leadership, administrative guidance, and support services to support clinical investigators with investigator-initiated and industry-sponsored research projects. The mission of the CRSO is to make it easier for the CHOP research community to conduct quality clinical research projects.
As part of the CRSO, the Clinical Trial Support program provides guidance to study teams with administrative aspects of study start-up and management and connects study teams with clinical trial tools and services provided at CHOP. Clinical Trial Support is also responsible for the administration of the OnCore Clinical Trial Management System at CHOP. As part of a dedicated team focused on study start-up, the Regulatory Coordinator will onboard studies quickly and effectively. The Regulatory Coordinator will also work closely with the IND/IDE Support Program to assist sponsor-investigator teams with FDA and IRB submissions.
The Regulatory Coordinator is responsible for any of the following:
Applies in depth knowledge of clinical research and independently coordinates the start-up activities of multiple studies including IRB, contract, and budget submissions
Monitors overall study start-up processes with a focus on expediting timelines
Provides resources and consulting on protocols or projects for study teams
Independent of the PI, assesses and critiques protocol feasibility and provides recommendations
Reviews Informed Consent Forms for consistency with contract and budget terms
Assists IND/IDE sponsor-investigator teams with IRB start-up submissions
Assists IND/IDE sponsor-investigator teams with initial and ongoing FDA submissions
Tracks FDA submission deadlines for sponsor-investigator INDs/IDEs
Maintains IND/IDE Support Program Intranet page
Schedules sponsor-investigator trainings and maintains training database
Assists the Recruitment Enhancement Core (REC) by evaluating the recruitment plan in the protocol and connect the study team with appropriate REC resources to help with feasibility and enrollment
Complies with institutional policies, standard operating procedures (SOPs) and guidelines
Complies with federal, state, and sponsor policies