Clinical Research Regulatory Coordinator II jobs in United States
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Mass General Brigham · 2 months ago

Clinical Research Regulatory Coordinator II

positionUnited States
timeFull-time
remoteRemote
seniorityMid Level
money$23.80/hr - $34.81/hr

Mass General Brigham is a not-for-profit organization that supports patient care, research, teaching, and community service. They are seeking a Regulatory Affairs Coordinator II who will be responsible for the collection, completion, and submission of regulatory documents for clinical trials, as well as maintaining regulatory documents during the IRB review process.

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H1B Sponsor Likelynote

Responsibilities

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

Qualification

Regulatory document submissionInformed Consent developmentIRB guidelines knowledgeComputer literacyAnalytical skillsCommunication skillsInterpersonal skillsOrganizational skillsAttention to detailTeamwork

Required

Bachelor's Degree Healthcare Management required or Bachelor's Degree Related Field of Study 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

Benefits

Comprehensive benefits
Career advancement opportunities
Differentials
Premiums
Bonuses
Recognition programs

Company

Mass General Brigham

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Mass General Brigham specializes in providing medical treatments and health diagnostics services.
dateFounded in 1994
location
Somerville, Massachusetts, USA
people-size10001+ employees
web-link
https://www.massgeneralbrigham.org

H1B Sponsorship

Mass General Brigham has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (77)
2024 (61)
2023 (93)
2022 (70)
2021 (80)
2020 (29)

Funding

Current Stage
Late Stage

Leadership Team

E
Erin Flanigan
SVP, Human Resources, Community, Specialty Hospital Division
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O’Neil A. Britton
Chief Integration Officer, Executive Vice President
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