Senior Regulatory Coordinator - Comprehensive Integrated Research Operations (CIRO)

About the role

The Senior Regulatory Coordinator within the Comprehensive Integrated Research Operations (CIRO) department serves as the administrative resource and liaison involved in supporting the business aspects of the clinical research enterprise. The position is responsible for leading and performing study-specific regulatory and safety reporting for a group of investigators, within multiple cost centers in the Department of Internal Medicine. This individual will support study-start up activities including IRB/Ancillary committee submissions, and maintenance of regulatory records throughout the life project for assigned cost centers.

Responsibilities

• Assist PI with investigator-initiated studies across multiple agencies, including protocol development, reviewing consent forms, budget planning and following-up with system set-up.
• Interface with study sponsors and study team members during study start-up and maintenance regarding regulatory documents, other regulatory issues, or contract modifications.
• Provide updates as required, escalate as appropriate.
• Lead Internal Medicine’s Quality Improvement activities for Clinical Research Enterprise.
• Perform study start-up activities, including submission of study documents to the Institutional Review Board (IRB).
• Maintain study timeline goals, monitor progress, and escalate delays appropriately.
• Collaborate with study team members to ensure regulatory documents are completed accurately and in accordance with requirements.
• Complete and maintain study file documents according to the requirements of ICH GCP E6 and applicable Regulatory Agency guidance and standards.
• Update protocol and study information into the Clinical Trial Management System (Velos) for team collaboration.
• Provide assistance to study monitors during routine monitor visits or audits.
• Support internal implementation of general principles of GAAP standards in reviewing financial compliance and consistency with contracts/agreements over the life of the project, following institutional and sponsor guidelines.
• Support the management or perform analytical and financial activities associated with cost studies, forecasting, planning, and managing clinical portfolios, including close-out of projects.
• Facilitate reporting and updates to study teams on the financial status of the clinical projects.
• Manage and perform activities related to multiple areas of clinical research project administration, including cross-functional duties and responsibilities across clinical research projects.

Requirements

• Six (6) years of work experience in healthcare or research setting.
• Relevant education may be substituted for experience on a year for year basis.
• Experience in a environment requiring an understanding of regulations governing clinical research (CFR, GCP, HIPAA) and statutes and guidelines relevant to regulatory affairs in clinical research.

Qualifications

• Master’s Degree in health sciences, biology, nursing, or a related field.

Skills

• Communication
• Multitasking
• Time management
• Interpersonal skills
• Computer skills