Research Associate

The General Hospital Corporation; Boston (MA); On-site; USD 28,000 - 40,000; Full time

Job summary

The Brigham and Women's Hospital, Inc. is seeking a regulatory professional to ensure clinical trial regulatory requirements are met under supervision.

You will work with clinical teams, IRBs, sponsors, and federal agencies, receiving training on governing regulations. Responsibilities include maintaining study binders, submitting protocol amendments and safety reports, updating consent documents, and reporting adverse events.

Qualifications

• Bachelor's Degree in a related field required; experience in lieu of degree acceptable.
• 1-2 years research-related experience preferred.
• Attention to detail and knowledge of clinical research protocols.

Responsibilities

• Maintain and organize study regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to IRB.
• Revise informed consent documents with updated risk information or protocol requirements.
• Manage adverse event and deviation documentation and report to sponsor/IRB.
• Maintain source documentation of correspondence with IRB, investigators, and sponsors.
• Collect, complete and submit essential regulatory documents to regulatory entities.
• Participate in monitoring visits and maintain records of visits.

Skills

Attention to detail

Regulatory knowledge

Clinical research

Communication

Education

Bachelor's Degree Related Field

Job description

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. The CRRCI will be trained on the institutional and federal regulations governing clinical research.

Does this position require Patient Care? No

Essential Functions

• 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.
• 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 maintain a record of all correspondence related to these visits

Qualifications

Education

Bachelor's Degree Related Field of Study required

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

Experience

Research Related Experience 1-2 years preferred

Knowledge, Skills and Abilities

• Attention to detail.
• Ability to recognize compliance and data integrity issues and respond appropriately.
• Working knowledge of clinical research protocols.
• Ability to communicate effectively with patients, vendors, contract research organizations and professional staff.
• Effective interpersonal and communication skills.

Additional Job Details (if applicable)

Remote Type

Onsite

Work Location

77 Avenue Louis Pasteur

Scheduled Weekly Hours

10

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.

EEO Statement

2200 The Brigham and Women's Hospital, Inc. 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 a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at (857)-282-7642.

Mass General Brigham Competency Framework

At Mass General Brigham, our competency framework defines what effective leadership "looks like" by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our syste