Job Description:About Brown Brown University (https://www.brown.edu/about) is a leading research university distinct for its student-centered learning and deep sense of purpose. Our students, faculty and staff are driven by the idea that their work will have an impact in the world. Brown University offers a flexible work/life balance; summer hours, winter break and a comprehensive Benefits package including time off, annual paid holidays; benefits offerings including health, dental, vision, tuition assistance, retirement, wellness, employee discounts and more. To learn about Brown University’s benefits, visit the University Human Resources web page here (https://www.brown.edu/about/administration/human-resources/benefits) for further information. About the OpportunityBrown HRPP is growing! As part of the BIRCH initiative (http://birch.brown.edu/) , Brown will soon be the main HRPP and Institutional Review Board (IRB) of record for Brown, Lifespan and Care New England health systems, and our HRPP is growing to meet this increased responsibility. The HRPP will be responsible for approximately 4000 protocols across eight institutions, spanning every area of academic and clinical research. The University is hiring multiple positions in the role of Human Research Protection Program (HRPP) Administrator and Senior Human Research Protection Program (HRPP) Administrator. The candidate's education, experience and qualifications will determine which position they are offered. Human Research Protection Program (HRPP) AdministratorThe HRPP Administrator is responsible for the administration and implementation of the Human Research Protection Program (HRPP) and Institutional Review Board (IRB) policies and procedures related to the conduct of human subjects research studies at Brown University, Lifespan, and Care New England. The HRPP Administrator ensures that all biomedical and behavioral human subjects research activities conducted at Brown University, Lifespan, and/or Care New England comply with federal regulations, state and local law, institutional policies, and AAHRPP accreditation standards. The HRPP Administrator conducts non-committee reviews and works collaboratively and independently with faculty, staff, and students. This role also supports IRB Committee meetings by preparing meeting agendas, materials, and managing meeting attendance. Senior Human Research Protection Program (HRPP) AdministratorThe Senior HRPP Administrator is responsible for the administration and implementation of the Human Research Protection Program (HRPP) and Institutional Review Board (IRB) policies and procedures related to the conduct of human subjects research studies at Brown University, Lifespan, and Care New England. The Senior HRPP Administrator ensures that all biomedical and behavioral human subjects research activities conducted at Brown University, Lifespan, and/or Care New England comply with federal regulations, state and local law, institutional policies, and AAHRPP accreditation standards. The Senior HRPP Administrator conducts non-committee reviews and works collaboratively and independently with faculty, staff, and students. This role supports IRB Committee meetings, is responsible for preparing meeting agendas and materials, taking minutes, and advising IRB members on applicable regulations, policies, and review criteria. This position maintains a knowledge and understanding of current federal, state regulations, state and local law, and institutional policies and departmental SOPs. QualificationsHuman Research Protection Program (HRPP) AdministratorExperience Required:
Bachelor’s degree and 3 years of related experience or equivalent combination of education and experience.
Working knowledge of federal regulations protecting human subjects.
Preferred:
Experience working in an HRPP office within an academic or clinical hospital/research setting.
At least 3 years of related experience working in a research compliance setting, either in administration or conducting research.
Experience with electronic submission systems.
Competencies
Thorough understanding of current federal and State regulations regarding human subjects research and ethical principles, Institutional policies, and integrated HRPP SOPs;
Ability to practically apply federal and state regulations as well as institutional policies to research submissions under review;
Ability to independently and competently handle protocol intake and pre-review;
Ability to handle confidential documents and sensitive information;
Experience with high volumes and rigid deadlines while maintaining attention to detail;
Ability to multitask and prioritize workloads;
Excellent interpersonal, oral and written communication skills;
Ability to work independently and use judgment and discretion in potentially controversial matters;
Ability to work with limited supervision and also serve as a strong team member;
Participation in continuing education and national and/or regional organizations devoted to promoting research ethics and the protection of human subjects;
Proficiency in Huron electronic IRB submission system, Microsoft Office applications, Google platforms, Adobe and other commonly used software;
Demonstrated ability to support a community of diverse perspectives and cultures in an inclusive environment.
Senior Human Research Protection Program (HRPP) AdministratorEducation and Experience Required:
Bachelor’s degree and 5+ years of related experience or equivalent combination of education and experience.
In-depth understanding of applicable laws, regulations, and policies related to human subjects research, including FDA regulations.
Experience working in an academic or clinical research setting.
Preferred:
CIP certification or willingness/ability to obtain CIP certification within two years of hire.
Knowledge of clinical trials, clinical trial registration, and clinical trial results reporting is highly desirable.
Must demonstrate an in-depth understanding of operational requirements pertaining to the management and implementation of protocol review processes.
Comfortable managing and performing work in an electronic system.
Competencies
In-depth understanding of current federal and State regulations regarding human subjects research and ethical principles, Institutional policies, and integrated HRPP SOPs;
Ability to practically apply federal and state regulations as well as institutional policies to research submissions under review;
Ability to independently and competently handle protocol reviews;
Ability to handle confidential documents and sensitive information;
Experience with high volumes and rigid deadlines while maintaining attention to detail;
Ability to multitask and prioritize workloads;
Excellent interpersonal, oral and written communication skills;
Ability to work independently and use judgment and discretion in potentially controversial matters;
Ability to work with little supervision and also serve as a strong team member;
Participation in continuing education and national and/or regional organizations devoted to promoting research ethics and the protection of human subjects;
Proficiency in an electronic IRB submission system, Microsoft Office applications, Google platforms, Adobe and other commonly used software;
Demonstrated ability to support a community of diverse perspectives and cultures in an inclusive environment.
Additional Information Applicants are asked to include a resume with their application. We are unable to offer Visa Sponsorship for this position. All offers of employment are contingent upon a criminal background check and education verification satisfactory to Brown University. Benefits of Working at Brown:Information on the Benefits of Working at Brown can be found here (https://www.brown.edu/a-z/benefits-working-brown) . Recruiting Start Date:2024-04-18Job Posting Title:Human Research Protection Program (HRPP) Administrator/ Senior Human Research Protection Program (HRPP) AdministratorDepartment:Office of Research IntegrityGrade:Grade 9Worker Type:EmployeeWorker Sub-Type:RegularTime Type:Full timeScheduled Weekly Hours:37.5Position Work Location:Remote EligibleSubmission 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.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 (https://go.brown.edu/equal-employment-opportunity) , Brown University provides equal opportunity and prohibits discrimination, harassment and retaliation based upon a person’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.
