Title: Clinical Research Coordinator: Regulatory
Company: White Plains Hospital
Location: WPH Center for Cancer Care
The Regulatory Coordinator works under the direction of the Principal Investigator,Cancer Program Director and in collaboration with the Clinical Trials Office to complete the regulatory requirements of the clinical research project. Coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with policies as well as federal regulation and ICH/GCP guidelines. Works interactively with the Office for OHRS, QACT, and the Clinical Trials Offices at WPH. Remain informed of current federal, state, and local regulations regarding clinical research. Assist in obtaining initial documents for clinical trial procurement and site selection. Develop the consent form, HIPAA authorization form, and other IRB-required forms specific to each protocol. Oversee new study initiation process and provide regulatory guidance/support throughout the duration of the project. Report pertinent safety data and deviation notifications to the IRB. Prepares for internal and external regulatory reviews for clinical research. Coordinator acts in accordance with all local, state, federal and IRB policies and procedures.
SOCRA Exp: 8/15/2020