Clinical Research Regulatory Coordinator I

Site: Mass General Brigham Incorporated

 

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

General Summary/Overview Statement:

The Clinical Research Regulatory Coordinator I (CRRCI) 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. The CRRCI will be trained on the institutional and federal regulations governing clinical research. This position does not involve patient contact.

Principal Duties and Responsibilities:

The following regulatory duties will be performed under general supervision by the Clinical Research Manager:

· Maintain and organize study specific regulatory binders

· 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

· Manage adverse event 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

· Ensure appropriate documentation of delegation and training for all study staff members

· Maintain screening and enrollment logs



Skills/Abilities/Competencies Required

· Careful attention to detail

· Good organizational skills

· Ability to follow directions

· Good communication skills

· Computer literacy

· Working knowledge of clinical research protocols

 

Qualifications

Education: Bachelor's Degree Related Field of Study required

Can this role accept experience in lieu of a degree? Yes

Licenses and Credentials: n/a

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)

Working Conditions:

· Duties will be performed remotely

 

Remote Type

Remote

 

Work Location

101 Merrimac Street

 

Scheduled Weekly Hours

40

 

Employee Type

Regular

 

Work Shift

Day (United States of America)

 

Pay Range

$19.76 - $28.44/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.

 

EEO Statement:

Mass General Brigham Incorporated is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided