Regulatory Affairs Coordinator II

Mass General Brigham; Boston (MA); Remote; USD 60,000 - 90,000; Full time

Job summary

Mass General Brigham seeks a Regulatory Affairs Coordinator to ensure compliance for clinical trials. This remote role involves collaborating with various stakeholders to manage submissions and maintain regulatory documentation. Ideal candidates will have a BA/BS and strong organizational and communication skills.

Qualifications

• Detail-oriented with the ability to manage multiple projects.
• Strong organizational skills required.
• Excellent oral and written communication skills.

Responsibilities

• Facilitate initial new trial submission for SRC and IRB review.
• Develop the Informed Consent document for clinical trials.
• Maintain a working knowledge of IRB guidelines.

Skills

Detail-orientation

Organizational skills

Communication skills

Education

BA/BS

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

The Regulatory Affairs Coordinator (RAC) will work with investigators, study staff, Institutional Review Boards (IRBs), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements are met for clinical trials. This role reports to the Regulatory Affairs Research Manager and works closely with research teams across the Cancer Center to ensure regulatory compliance for multiple cancer trials.

Qualifications

Principal Responsibilities

The Following Duties Will Be Performed Independently:

• Facilitate initial new trial submission for SRC and IRB review
• Develop the Informed Consent document for the clinical trial protocol with the input of the trial’s sponsor and Principal Investigator
• Correspondence with the IRB, investigators, and sponsors throughout the review process
• Provide clinical trial sponsors with required regulatory documents during study initiation process
• Prepare and submit protocol amendments during the IRB review process
• Creation and maintenance of electronic regulatory binders
• Maintain a working knowledge of the IRB’s current guidelines and forms for protocol and consent form submissions
• Specialize in certain disease groups, which includes maintaining study staff lists
  
  

Please note that this is a remote role and there will be no physical office/location. Applicants may work in all states with the following exceptions: WY, ND, Puerto Rico, and the U.S. Virgin Islands.

Qualifications

Additional Job Details (if applicable)

• BA/BS required
• Detail-orientation with the ability to manage multiple projects simultaneously
• Strong organizational skills
• Excellent oral and written communication skills
• Prior regulatory or clinical research experience with an academic medical center or industry a plus
  
  

Candidates with no relevant experience will be hired as a RAC I

Remote Type

Remote

Work Location

101 Merrimac Street

Scheduled Weekly Hours

40

Employee Type

Regular

Work Shift

Day (United States of America)

EEO Statement:

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.