Montclair State University

Reporting to the Director of Research Compliance and Regulatory Programs, the Human Research Protection Program Administrator (HRPP) supports the Office of Research by overseeing and managing the Institutional Review Board (IRB) and its operations.. Maintain metrics and prepare reports for IRB including (but not limited to) turnaround times and type of reviews.. Oversee the administration of IRB Reliance Agreements and Independent Investigator Agreements.. Provide expertise for mentoring and professional development of staff and IRB members; prepare and teach departmental compliance modules and assist with educational presentations to the research community.. A minimum of four years of progressive experience in quality assurance, IRB operations, sIRB/Reliance processes, or quality assurance processes in research.

program administrator

IMPORTANT APPLICATION INSTRUCTIONS:
Upload Resume or Curriculum Vitae for automatic population of information to the application.
The contact information, work experience, and education listed on your Resume/CV will be parsed and input into your Montclair application.
Review information and double-check all fields containing information that the system parsed – the software is intelligent, but you need to verify that the data is accurate.
In the “My Experience” section, you will find a Resume/CV upload option where you can submit your cover letter and all other supporting documents.
Note: If you have an expansive CV, we recommend that you apply manually and only include the positions you have held in the last ten (10) years. You will then be able to attach your Resume/CV, as well as all other supporting documentation in the "My Experience" section of your application.
Job Description
SUMMARY:
Reporting to the Director of Research Compliance and Regulatory Programs, the Human Research Protection Program Administrator (HRPP) supports the Office of Research by overseeing and managing the Institutional Review Board (IRB) and its operations. This position ensures that human subjects research conducted under the auspices of Montclair State University are carried out in such a manner that protects the rights and welfare of participants in research and complies with institutional, local, state, and federal regulations. The Administrator supervises staff assigned to provide administrative and regulatory support to the IRB, including working in collaboration with the Board in the development and maintenance of appropriate policies, procedures, processes, and records.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Oversee the administration of the Human Research Protection Program (HRPP) and IRB, including the supervision of staff.
Assist in preparation of research accreditation applications (for example AAHRPP).
Maintain metrics and prepare reports for IRB including (but not limited to) turnaround times and type of reviews.
Oversee the administration of IRB Reliance Agreements and Independent Investigator Agreements.
Assess level of compliance review needed to process work assigned to staff.
Provide expertise for mentoring and professional development of staff and IRB members; prepare and teach departmental compliance modules and assist with educational presentations to the research community.
Serve as a resource in making project regulatory determinations and assist the Director with making final determinations.
Serve as an IRB member, attend Board meetings, facilitate resolution of controverted issues, and assist in the preparation of minutes and post-meeting communications with researchers.
Participate in the quality assurance review of analyst work and assists in resolving related issues.
Develop and implement improvements and ensure follow-up of actions, as appropriate, for the purpose of managing risk in the research program.
Develop training requirements as required and as appropriate for IRB members, investigators, and staff, and ensure that training is completed on a timely basis.
Ensure compliance with federal, state and local regulations through the development and implementation of institutional policies and procedures in collaboration with the IRB and other key stakeholders.
Conduct pre-reviews of protocols and applications, and recommend level of review.
Draft meeting agenda, assemble meeting information, and ensure a quorum will be in attendance.
Manage a large volume of submissions, deadlines, and customer expectations.
Performs other duties as assigned.
Management retains the right to add or change job duties at any time.
QUALIFICATIONS:
REQUIRED:
Bachelor’s degree from an accredited college or university.
A minimum of four years of progressive experience in quality assurance, IRB operations, sIRB/Reliance processes, or quality assurance processes in research.
Working knowledge of and experience with Microsoft Office programs: Word, Excel, PowerPoint, and Access.
Ability to understand, analyze, interpret, and apply established law, regulations, procedures, precedents, and guidelines to all areas of IRB work.
Excellent written and oral communication skills, strong problem solving and decision-making skills and the ability to make decisions independently.
Ability to take initiative and simultaneously manage multiple projects with minimal supervision.
Strong organizational and teamwork skills to prioritize and handle multiple tasks simultaneously.
PREFERRED:
Knowledge of budget principles, techniques, and financial management e-systems.
Previous experience with accreditation (AAHRPP).
Prior experience supervising employees.
PROCEDURE FOR CANDIDACY
Applicants should include a resume and cover letter describing how their background, skills and education match the needs of the University. When applying, please take a moment to carefully read and follow the steps in the application instruction.
Department
Research Compliance and Regulatory Programs
Position Type
Professional - Non-Faculty
Contact Information:
For questions or concerns, please contact Human Resources' Workday Recruiting Support at 973-655-5000 (Option 2), or email
talent
@montclair.edu
.
EEO/AA Statement
Montclair State University is an Equal Opportunity/Affirmative Action institution with a strong commitment to diversity.
Additional information can be found on the website at

www.montclair.edu/human-resources/about-us/eo-aa-and-diversity/
Title IX and 34 C.F.R. 106 Policy
Montclair State is required by Title IX and 34 C.F.R. 106 not to discriminate on the basis of sex or gender, and does not discriminate on the basis of sex or gender in the operation of education programs and activities. The requirement to not discriminate on the basis of sex or gender in the operation of education programs and activities extends to admission and employment. For further details, please visit:
https://www.montclair.edu/human-resources/job-seekers/

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