Job Description:

The Human Research Specialist provides regulatory support for the People, Place & Health Collective (PPHC) at Brown University. This position will play a critical role in managing the regulatory requirements and study procedures of the teamâ™s flagship projects. The incumbent will prepare and edit study materials, including consent forms and other human subjects documents. The incumbent will also prepare IRB submissions, including new applicants, continuing reviews, amendments, and manage unanticipated problems and protocol deviations. In this manner, the incumbent will serve as the primary liaison between the PPHC and the Brown University Human Research Protection Program (HRPP), promptly addressing all pre-review and IRB board comments. The incumbent will play a particularly important role managing the teamâ™s clinical trials, including submission and management of ClinicalTrials.gov registrations, data safety & monitoring plans (DSMPs), and annual reports. Finally, the incumbent will be responsible for managing and executing the teamâ™s data use agreements (DUA) with state agencies and other entities, in partnership with the Brown University HRPP data use agreement office. This position will serve as a resource to the entire PPHC team and will also collaborate with investigators in other departments within Brown and at other collaborating sites.

Job Qualifications 

Required:
Bachelorâ™s Degree in related field or equivalent combination of education and experience may be considered. 
At least 3 or more years of experience required. 
Demonstrated experience writing IRB protocols and responding to IRB and HRPP reviewer comments
Demonstrated experience working with clinical trials, including management of DSMPs and DSMBs
Proficient in the use of electronic submission systems or had demonstrated ability to quickly learn new electronic systems.
Must have working knowledge of ICH Guidelines, US. Code of Federal Regulations, and ethical principles that guide clinical research

Possesses a willingness and ability to support a diverse and inclusive environment 

Preferred:
Effective presentation, facilitation, and communication skills, both oral and written
Effective interpersonal and organizational skills.
Motivated, independent, and self-starting.
Results-oriented team player
Creative, flexible, comfort with higher management
 

This is a fixed term position with a current end date of 9/1/2023 which may be extended based upon available funding

All offers of employment are contingent upon a criminal background check and education verification satisfactory to Brown University.

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Submission Guidelines:

Please note that in order to be considered an applicant for any staff position at Brown University you must submit an application form for each position for which you believe you are qualified. Applications are not kept on file for future positions. Please include a cover letter and resume with each position application.

Vaccination Requirements:

In order to maintain 90% or greater universal vaccination rates on campus, all newly hired employees at Brown University must receive the final dose of the COVID-19 vaccine before they begin work, unless they are approved for a medical or religious exemption. All employees must also receive a COVID-19 booster within thirty (30) days of becoming eligible. For more information, please visit the Healthy Brown site.

Still Have Questions?

If you have any questions you may contact employment@brown.edu.

EEO Statement:

Brown University is an E-Verify Employer.

As an EEO/AA employer, Brown University provides equal opportunity and prohibits discrimination, harassment and retaliation based upon a personâ™s race, color, religion, sex, age, national or ethnic origin, disability, veteran status, sexual orientation, gender identity, gender expression, or any other characteristic protected under applicable law, and caste, which is protected by our University policies.

About Brown University

Located in historic Providence, Rhode Island and founded in 1764, Brown University is the seventh-oldest college in the United States. Brown is an independent, coeducational Ivy League institution comprising undergraduate and graduate programs, plus the Alpert Medical School, School of Engineering, Executive Master of Healthcare Leadership and the IE Brown Executive MBA.

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