Clinical Research Regulatory Coordinator I

Massachusetts General Hospital; Boston (MA); Remote; USD 125,000 - 150,000; Full time

Job summary

A leading healthcare institution in Boston is seeking a Clinical Research Regulatory Coordinator I to ensure regulatory requirements for clinical trials are met. The role involves coordinating with clinical teams and regulatory agencies, requiring attention to detail and strong organizational skills. Candidates must have a Bachelor’s degree in a related field. This position offers a remote work model and a salary range of $19.76 - $28.44 hourly.

Qualifications

• Bachelor's Degree in a related field required.
• Ability to follow regulations and guidelines in clinical research.

Responsibilities

• Maintain and organize study-specific regulatory binders.
• Prepare and submit protocol amendments and safety reports to the IRB.
• Manage documentation for adverse events and report to the sponsor.

Skills

Attention to detail

Organizational skills

Ability to follow directions

Computer literacy

Knowledge of clinical research protocols

Education

Bachelor's Degree Related Field

Job description

Overview

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 invite all applicants to join us and experience what it means to be part of Mass General Brigham.

Job Summary

The Clinical Research Regulatory Coordinator I (CRRCI) 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. This position does not involve patient contact.

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/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
• Submit Data and Safety Monitoring Reports
• 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 file all monitoring visit correspondence
• Ensure appropriate documentation of delegation and training for all study staff members
• Maintain screening and enrollment logs

Qualifications

Education: Bachelor\'s Degree Related Field of Study required
Can this role accept experience in lieu of a degree? Yes

Licenses and Credentials: n/a

Experience / Knowledge, Skills and Abilities:

• Careful attention to detail
• Good organizational skills
• Ability to follow directions
• Computer literacy
• Working knowledge of clinical research protocols

Additional Job Details

Working Conditions: Duties will be performed remotely

Remote Type: Remote

Work Location: 101 Merrimac Street

Scheduled Weekly Hours: 40

Employee Type: Regular

Work Shift: Day (United States of America)

Pay Range: $19.76 - $28.44/Hourly

Grade: 5

EEO Statement

Mass General Brigham Incorporated 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.