Regulatory Affairs Coordinator I - Koo Laboratory

About the role

Site: The Brigham and Women's Hospital, Inc.

Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job Summary

Works under general supervision to ensure the regulatory requirements for clinical trials are met. This position involves working with clinical teams, Institutional Review Boards (IRB), clinical trial sponsors, and federal regulatory agencies. Will be trained on the institutional and federal regulations governing clinical research.

Does this position require Patient Care?

No

Essential Functions

• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents to include new risk information and/or updated protocol requirements through the course of the study.
• Maintain and organize study-specific regulatory binders.
• Manage adverse events and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
• Submit Data and Safety Monitoring Reports.
• Maintain source documentation of correspondence with the IRB, investigators, and sponsors throughout the clinical trial process.
• Collect, complete, and submit essential regulatory documents to various regulatory entities.
• Participate in monitoring visits and file all monitoring visit correspondence.

Qualifications

• Education
• Bachelor's Degree Related Field of Study required
• Can this role accept experience in lieu of a degree?
• Yes
• Licenses and Credentials
• Experience

Knowledge, Skills and Abilities

• Careful attention to detail.
• Good organizational skills.
• Ability to follow directions.
• Computer literacy.
• Working knowledge of clinical research protocols.
• Additional Job Details (if applicable)
• Remote Type
• Onsite
• Work Location
• 20 Shattuck Street
• Scheduled Weekly Hours
• 40
• Employee Type
• Regular
• Work Shift
• Day (United States of America)

Pay Range $20.16 - $29.01/Hourly

Grade

5

At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors.

The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package.

In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.