Clinical Research Regulatory Coordinator II in London

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

Employee Type

Regular

Work Shift

Day (United States of America)

Pay Range

$ $34.81/Hourly

Grade

6At 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