Clinical Research Associate

1200 The General Hospital Corporation; Boston (MA); Hybrid; USD 57,767,000 - 83,126,000; Full time

Job summary

The General Hospital Corporation, part of Mass General Brigham, seeks a Clinical Research Associate to ensure regulatory requirements for clinical trials are met. You will work with clinical teams, IRBs, sponsors, and federal agencies, gaining training on institutional and federal regulations governing clinical research.

Remote Type Hybrid; Work Location 55 Fruit Street. The role requires a Bachelor's in a related field and 1–2 years of research experience, with responsibilities spanning

Qualifications

• Bachelor's Degree in a Related Field of Study required.
• Research-Related Experience 1-2 years preferred.
• Attention to detail and strong regulatory knowledge are essential.

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 reflect new risks or protocol updates.
• Manage adverse event and deviation documentation and report to sponsor/IRB.
• Maintain source documentation of IRB communications and trial correspondence.
• Submit essential regulatory documents to regulatory entities.
• Participate in monitoring visits and document related communications.

Skills

Attention to detail

Compliance awareness

Clinical research protocols

Communication skills

Education

Bachelor's Degree in a 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 Clinical Research Associate 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.

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

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: 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.

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