Clinical Research Regulatory Coordinator I

@ Mass General Brigham

Job Overview

The Clinical Research Regulatory Coordinator I at Mass General Brigham ensures that regulatory requirements for clinical trials are met while supporting patient care, research, teaching, and community service.

Principal Duties and Responsibilities

• Maintain and organize study-specific regulatory binders
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB
• Revise informed consent documents with updated risk and protocol information
• Manage adverse event and deviation/violation documentation and reporting
• Submit Data and Safety Monitoring Reports
• Maintain source documentation of correspondence with IRB, investigators, and sponsors
• Collect, complete, and submit essential regulatory documents
• Participate in monitoring visits and file related correspondence
• Document delegation and staff training
• Maintain screening and enrollment logs

Skills and Qualifications

Candidates must exhibit careful attention to detail, good organizational and communication skills, computer literacy, and a working knowledge of clinical research protocols. A Bachelor's Degree in a related field is required; however, experience may substitute for formal education.

Working Conditions

This position is performed remotely. Scheduled weekly hours are 40 during day shifts in the United States.

Key skills/competency

• Regulatory Compliance
• Clinical Trials
• IRB Submissions
• Adverse Event Reporting
• Documentation
• Data Monitoring
• Protocol Management
• Training
• Organization
• Communication