Clinical Research Regulatory Coordinator II

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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
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…