The Human Research Specialist provides regulatory support for the Hassenfeld Study. The incumbent prepares and edits study materials including study protocols, informed consent forms, and study-related patient materials. The incumbent submits new applications, continuing reviews, amendments, unanticipated problems, and protocol deviations. The incumbent serves as the primary liaison with the Brown Human Research Protection Program (HRPP) Â Â promptly addressing all pre-review and committee comments. The incumbent serves as a resource to the entire Hassenfeld study team as well as collaborating investigators from other departments within Brown and related sites.
Major responsisiblities include: Serves as key resource for IRB requirements and guidelines, and regulatory aspects , Coordinates all IRB submissions to HRPP and maintains approvals ,and Prepares and maintains regulatory files â‹
Bachelorâ™s Degree in related field or equivalent combination of education and experience may be considered. 3 or more years of experience required.
Demonstrated experience writing IRB protocols and responding to IRB and HRPP reviewer comments
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
Effective presentation, facilitation, and communication skills, both oral and written
Effective interpersonal and organizational skills.Â Motivated and self-starting.
Results-oriented team player
Creative, flexible, comfort with higher management
Possesses a willingness and ability to support a diverse and inclusive environment
Background Check: Criminal and Education required
This is a fixed-term position with a current end date of 9/30/21. Extension of position will depend of available funding.
Recruiting Start Date:
Job Posting Title:
Human Research Specialist
School of Public Health
Fixed Term (Fixed Term)
Scheduled Weekly Hours:
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.
Brown University is committed to fostering a diverse and inclusive academic global community; as an EEO/AA employer, Brown considers applicants for employment without regard to, and does not discriminate on the basis of, gender, sex, sexual orientation, gender identity, national origin, age, race, protected veteran status, disability, or any other legally protected status.
Internal Number: REQ167590
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.