Research Associate

Brigham and Women's Hospital; Boston (MA); On-site; USD 28,000 - 40,000; Full time

Job summary

The Brigham and Women's Hospital, Inc. is seeking a Regulatory Affairs professional to ensure compliance with clinical trial regulations under general supervision. You will work with IRBs, sponsors, and federal agencies, gaining training on institutional and federal requirements governing clinical research.

Onsite position with regular day shift, located at 77 Avenue Louis Pasteur. The role includes preparing amendments, safety reports, and maintaining regulatory documentation throughout the

Qualifications

• Bachelor's Degree in related field required
• Research related experience 1-2 years preferred
• Attention to detail and accuracy in regulatory work
• Working knowledge of clinical research protocols
• Ability to communicate effectively with patients, vendors, CROs and staff
• Strong interpersonal and communication skills

Responsibilities

• Maintain and organize study-specific regulatory binders.
• Prepare and submit protocol amendments, continuing reviews, and safety reports to the IRB.
• Revise informed consent documents with new risk info and updated protocol requirements.
• Manage adverse event and deviation/violation/exception documentation; report to sponsor/IRB.
• Maintain source documentation of correspondence with IRB, investigators, and sponsors.
• Submit essential regulatory documents to regulatory entities.
• Participate in monitoring visits and document correspondence.

Skills

Attention to detail

Compliance awareness

Clinical research protocols

Communication skills

Interpersonal skills

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

Licenses and Credentials

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

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.

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 system, and establish a strong talent pipeline.