Regulatory Affairs Coordinator I

Overview
The Regulatory Coordinator (RC) works under the direction of the Principal Investigator(s) and Clinical Research Manager to complete the regulatory requirements of the clinical research projects. Projects will focus on studying and treating Pulmonary Vascular Disease, primarily Pulmonary Hypertension but extending to other conditions such as Interstitial Lung Disease (ILD), Chronic Obstructive Pulmonary Disease (COPD), Idiopathic Pulmonary Fibrosis (IPF), etc. with investigational drugs and / or devices. The RC coordinates aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with MGB policies as well as federal regulation and ICH/GCP guidelines. This position will work collaboratively with a variety of personnel at all levels, including faculty and study team members of MGB and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations. The RC works interactively with the Office for Human Research Studies (OHRS), Office of Data Quality (ODQ) and the Clinical Trials Offices at the various MGB institutions.
This position is for onsite work with occasional remote time. Remote work may only be performed from New England states (CT, RI, MA, NH, VT, ME). Candidates must have the ability to work from our Boston, MA office for onsite days.
Located in Boston and the surrounding communities, Brigham and Women's Hospital (BWH) is an international leader in virtually every area of medicine and has been the site of pioneering breakthroughs that have improved lives around the world. Brigham and Women’s Health Care – the parent corporation for Brigham and Women’s Hospital, Brigham and Women’s Faulkner Hospital and the Brigham and Women’s Physician Organization – includes 150 outpatient practices with over 1,200 physicians. We serve patients from New England, throughout the United States, and from 120 countries around the world.
We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Responsibilities

• Regulatory Compliance
• Prepares and submits all protocol applications, amendments, continuing reviews, and informed consent documents for SRC and IRB review and approval
• Prepares and submits regulatory documentation that may include; IND/IDE applications, FDA annual reports, Serious Adverse Event reports, to the appropriate regulatory agencies including the Food and Drug Administration (FDA), sponsor DMC/DSMB etc.
• Prepares, maintains and organizes Regulatory files for each assigned study in compliance with study sponsor requirement; Industry sponsor, MGB sponsored etc.
• Maintains various regulatory tracking databases with information related to study recruitment, subject enrollment, and study progress and completion.
• Assists in the preparation and coordination of assigned study monitoring and auditing visits with study coordinator, Investigator, Industry Sponsors, and third party auditors.
• Clinical Trial Management
• Track and manage assigned new protocol start-up packet; initiate, facilitate and monitor study start-up progress to ensure established benchmarks are met.
• Communicate and collaborate with clinical trial key stakeholders through the start-up process, provide regular updates and ensure all start-up activities are completed
• Create and maintain tracking for all subsequent submissions to the IRB; protocol & consent amendments, all required safety reporting, all required deviation, exception or other event reporting. Ensure various regulatory reporting requirements are met; Study Sponsor, FDA, IRB etc.
• Leadership and Professionalism
• Maintain working knowledge of current regulations, regulatory guidance and / or local policies
• Assists Clinical research Manager with regulatory based training and implementation of new or revised regulation, guidance and / or local policy
• Present regulatory status for disease group portfolio at applicable research meetings
  

Qualifications

• Bachelor’s Degree required. Experience working in a medical or scientific research setting or comparable technology orientated business environment preferred. Experience working in Epic or other electronic medical record (EMR) system and fundamental knowledge of the conduct of clinical trials is preferred.
  

Required Competencies

• Must be able to perform day to day responsibilities duties as described above with regular and ongoing training and supervision. Attains and can demonstrate fundamental knowledge and is somewhat proficient in some or all of the following areas: MGB, ICH/GCP, FDA policy / guidance / regulation; an understanding of the IRB submission & approval process; Regulatory Binder maintenance; PI Initiated / Multi-Center Trials; protocol and consent design and development and FDA / IND / IDE and other regulatory required submissions
• Must possess excellent written and oral communication skills, maintain confidentiality of information, demonstrate good decision-making and judgment and have attention to detail and follow-through skills.
• Demonstrated organization and time management/prioritization skills with the ability to work independently are required.
• Must be proficient in the use of computers, Microsoft applications and databases.
• Requires experience with medical terminology.
  

Primary Location
MA-Boston-BWH Boston Main Campus
Work Locations
BWH Boston Main Campus
Job
Clinical
Organization
Brigham & Women's Hospital(BWH)
Schedule
Full-time
Standard Hours
40
Shift
Day Job
Employee Status
Regular
Recruiting Department
Brigham & Women's Hospital
Job Posting
Feb 27, 2024