Brown University Health · 21 hours ago
Research Regulatory Coordinator
Providence, RI
Full-time
Onsite
Mid Level
$58K/yr - $96K/yr
3+ years expBrown University Health is seeking a Research Regulatory Coordinator to ensure compliance with regulatory requirements in clinical research. The role involves overseeing clinical trials, advising staff on regulatory issues, and collaborating with investigators to manage the regulatory aspects of clinical studies.
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Responsibilities
Consults with and/or provides advice regarding regulatory documents and/or processes related to clinical trials conduct
Serves as the regulatory subject matter expert through all phases of a clinical study
Serves as a lead and mentor to other clinical research staff, to include the execution of new initiatives and process improvement
Develops and/or revises regulatory policies and procedures
Initiates and leads special projects, to include process improvement and regulatory training
Ensures proper regulatory compliance in accordance with sponsoring agency requirements
Liaises with sponsors, investigators and team members, providing trial information and updates as required in written, oral and meeting format, adhering to appropriate timelines
Develops protocols with the Principle Investigator and provides recommendations on research plan
Coordinates and facilitates the submission of Investigational New Drug (IND) and/or Investigational Device Exemption (IDE) applications
In collaboration with the Principle Investigator, interprets protocols and creates consent documents needed for clinical research study
Prepares regulatory approval applications, respond to stipulations, and shepherd applications and correspondence through the processes until approvals are obtained
Participates in Study Initiation Visits and Interim Monitoring Visits
Maintains study specific regulatory binder
Performs other duties as assigned
Qualification
Required
Bachelor's degree in health-related or scientific field, is required
Sound knowledge of all federal, local and state guidelines pertaining to Clinical Research
Must be an independent person, who is capable of making sound judgment pertaining to regulatory issues and have the ability to work independently within the scope of the job requirements
Strong-self-starter, interpersonal skills, and influence are necessary
Team-oriented with excellent oral and written communication skills
Strong problem-solving skills
Excellent self-management and organizational skills
Detail-oriented
Computer skills in Microsoft office
Comprehensive knowledge of FDA guidelines
Must be proficient in various database applications
Ability to foster smooth communications and teamwork among clinical research faculty, fellows and staff as well as external organizations necessary
SoCRA (Society of Clinical Research Associates) certified or eligible within 18 months of hire
3-5 years in direct clinical trial administration experience or relevant clinical development and regulatory experience
Understanding of compliance requirements with federal, state or local programmatic regulations are necessary
Company
Brown University Health
Brown University Health provides an integrated academic health system offering hospital services, outpatient care and clinical education.
10001+ employees
H1B Sponsorship
Brown University Health 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 (3)
2024 (2)
2022 (3)
2021 (1)
Funding
Current Stage
Late StageRecent News
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