Clinical Research Associate

Massachusetts General Hospital; Boston (MA); Hybrid; USD 57,767,000 - 83,164,000; Full time

Job summary

Mass General Brigham in Boston seeks a CRRCI regulatory specialist to ensure compliance with institutional and federal requirements for clinical trials. You will work with clinical teams, IRB, sponsors, and regulators to support study conduct.

The role requires attention to detail, knowledge of clinical research protocols, and strong communication with vendors and investigators. Hybrid work at 55 Fruit Street offers collaboration with a diverse team and opportunities to advance patient-focused

Qualifications

• Education: Bachelor's Degree in a Related Field of Study required.
• Experience: Research-Related Experience 1-2 years preferred.
• Knowledge, Skills and Abilities: Attention to detail, compliance awareness, communication with patients, vendors, CROs, and staff.

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 to include new risk information and protocol updates.
• Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to 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.

Skills

Attention to detail

Compliance awareness

Clinical research protocols

Effective communication

Interpersonal skills

Education

Bachelor's Degree in Related Field

Job description

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.

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.

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 throughout 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 in a Related Field of Study required

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: Hybrid
• Work Location: 55 Fruit Street
• Pay Range: $20.16 - $29.01/Hourly
• Grade: 5

Pay and Benefits

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

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, 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 system, and establish a strong talent pipeline. Combat disease. Hold a hand. Help people. Impact the world. Mass General Brigham is a passionate, welcoming community where minds meet caring hearts. Come be a part of the world’s most powerful force in medicine, where every role is important in changing lives. Are you ready? Our history includes New England hospitals founded over 200 years ago, some of the first and most prestigious hospitals in the world. Built on the legacy of two leading academic medical centers, we’re more than a system—we’re leaders in the practice of medicine. Mass General Brigham is committed to serving the community. We are dedicated to enhancing patient care, teaching and research, and taking a leadership role as an integrated health care system. We recognize that increasing value and continuously improving quality are essential to maintaining excellence.