Job Description
Site: Mass General Brigham Incorporated
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.
The Regulatory Affairs Coordinator II (RAC II) is responsible for the collection, completion and submission of regulatory documents to the clinical trial sponsors and the Institutional Review Board (IRB). The RAC II works independently to monitor, track and facilitate regulatory reports to and from all the IRB committees and if necessary, the clinical trial sponsor. The RAC II is also responsible for the maintenance of all clinical trial regulatory documents and files during the IRB review process. The position of RAC is also responsible for disseminating all updates on the clinical trial review process to the sponsor and the research study team.
Job Summary PRINCIPAL DUTIES AND 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
Provide clinical trial sponsors with required regulatory documents during study initiation process
Prepare and submit protocol amendments during the IRB review process
Create electronic regulatory binder
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
SKILLS/ABILITIES/COMPETENCIES REQUIRED:
Ability to work independently and as a team member
Careful attention to detail
Computer literacy
Analytical skills and ability to resolve problems
Excellent oral and written communication skills
Strong interpersonal skills
Strong organizational skills
Qualifications Education
Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study required
Can this role accept experience in lieu of a degree? No
Licenses and Credentials
Experience
Regulatory Affairs Experience 2-3 years required
Knowledge, Skills and Abilities
- Familiarity with Good Clinical Practice (GCP) guidelines and relevant regulations (e.g., ICH E6, 21 CFR, etc.).
- Understanding of the clinical trial process and the importance of regulatory compliance in protecting research subjects and ensuring data integrity.
- Strong organizational skills with attention to detail and the ability to manage multiple projects simultaneously.
- Excellent written and verbal communication skills.
- Proficiency in using relevant software and electronic systems for regulatory documentation management.
- Ability to interpret the acceptability of data results.
Additional Job Details (if applicable) Remote Type Remote
Work Location 101 Merrimac Street
Scheduled Weekly Hours 40
Employee Type Regular
Work Shift Day (United States of America)
Pay Range $23.80 - $34.81/Hourly
Grade 6
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. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package.
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.
Job Tags
Hourly pay, Full time, Shift work,