Clinical Research Associate

Mass General Brigham; Boston (MA); Hybrid; USD 57,877,000 - 83,124,000; Full time

Job summary

Mass General Brigham is seeking a regulatory professional to support clinical trials at 55 Fruit Street, Boston. Working under supervision, you will collaborate with clinical teams, IRB, sponsors, and federal regulators, and you will be trained on applicable regulations.

You will maintain study regulatory binders, submit amendments and continuing reviews, revise consent documents, manage adverse event records, and maintain source documentation and correspondence with IRB and sponsors throughout

Qualifications

• Bachelor's degree required.
• Research-related experience 1-2 years preferred.
• Strong attention to detail and ability to identify compliance and data integrity issues.
• Effective written and verbal communication with patients, vendors, CROs, and staff.
• Understanding of clinical research protocols and regulatory requirements.

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 risk information or protocol changes.
• Manage adverse event and deviation/violation/exception documentation and report to sponsor/IRB as required.
• 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 document related correspondence.

Skills

Attention to detail

Compliance awareness

Clinical research protocols

Communication skills

Interpersonal skills

Education

Bachelor’s Degree in a Related Field of Study

Job description

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

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.

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.