Research Regulatory Specialist

Site: The General Hospital Corporation

 

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.

 

The mission of the MGB’s Office of Clinical Research (OCR) is to increase the quantity, quality, and efficiency of clinical research at MGB. The MGB OCR nurtures and empowers the next generation of clinical research investigators and study staff by providing educational courses, guidance, and resources to the MGB clinical research community. Faculty-led consultation services and the project management support service core advise and provide logistical support to clinical research teams.
The Research Regulatory Specialist provides regulatory compliance activities for clinical research studies. This position ensures that all regulatory documentation is accurately prepared, maintained, and submitted following the ICH Good Clinical Practice (ICH GCP), FDA, IRB, and institutional guidelines. The role is critical in managing IND/IDE submissions, ClinicalTrial.gov registration and reporting, and IRB submissions.

 

Job Summary

Will guide investigators in the IRB review process and will assist with the preparation and submission of protocol documents to the IRB and other regulatory committees to ensure regulatory compliance.

Does this position require Patient Care?
No

Essential Functions
-

The preparation and submission of protocols to the IRB



-Assists with development of study documents including protocols and informed consent forms

-Advising researchers and research teams on the regulatory review process

-Tracking and facilitating the progress of new trials through the review process



-Maintain working knowledge of current regulations and MGB IRB policies and guidance’s

-Facilitate training for the research teams on changes to regulatory process or new regulatory requirements

-Track protocol status and alert Investigators and management team of regulatory actions required

 

Qualifications

Job DescriptionEducation
Bachelor's Degree Related Field of Study required or Master's Degree Related Field of Study preferred

Can this role accept experience in lieu of a degree?
No

Licenses and Credentials

Experience
Prior regulatory or clinical research experience with an academic medical center or industry 3-5 years required and

Knowledge, Skills and Abilities
- High level time management and organization skills.
- Excellent written and verbal communication skills.
- Knowledge of current and developing clinical research trends.
- Sound interpersonal skills.
- Ability to work independently and display initiative.
- Ability to identify problems and develop solutions.

 

Additional Job Details (if applicable)

 

Remote Type

Hybrid

 

Work Location

125 Nashua Street

 

Scheduled Weekly Hours

0

 

Employee Type

Per Diem

 

Work Shift

Day (United States of America)

 

Pay Range

$62,004.80 - $90,750.40/Annual

 

Grade

7

 

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:

1200 The General Hospital Corporation 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, disa