Job No: 503744 Work Type: Locations: San Diego Categories: Unit 9 - CSUEU - Technical Support Services, Probationary, Full Time, Research
Reporting to the Assistant VP of Research Affairs, the Regulatory Analyst/Educator shares responsibility for implementation of policies and procedures associated with SDSU affiliated human subject research consistent with federal and state regulations and University policies. The Regulatory Analyst/Educator must have a comprehensive knowledge of human research protection regulations and their application to ethical and responsible research practices. The Regulatory Analyst/Educator has significant contact with other Regulatory Analyst/Educators, the Institutional Review Board (IRB) Chair and the SDSU research community, including faculty investigators, students, research administration, and committee members.
The Regulatory Analyst/Educator must possess a working knowledge of research methods associated with social and behavioral sciences to properly review research proposals, to evaluate actions taken by investigators in response to IRB review, and to audit and ensure compliance with the approved protocols. Additional working knowledge of research methods in biological or clinical trials is also preferred. In addition, the Regulatory Analyst/Educator must be able to evaluate adverse events and assess possible violations or lack of compliance with human subject protection policy.
The Regulatory Analyst/Educator provides guidance to investigators in research protocol development, conducts review of protocol applications to identify problems and issues that may prohibit a complete review or compromise regulatory compliance, composes clear and concise written correspondence, maintains records in accordance with regulations and generates reports detailing HRPP activities. The Regulatory Analyst/Educator reviews protocol amendments, continuations and unanticipated problem reports and will assist in the preparation of agenda materials and minutes of convened committee meetings in accordance with federal requirements. The Regulatory Analyst/Educator will work with investigators throughout the application process as a resource of ethical research practices and federal, state & institutional policy. The Regulatory Analyst/Educator will develop methods to enhance communication with investigators, administrators & staff and serve as a liaison to technical staff for purposes related to the IRB information and web-based systems
The Regulatory Analyst/Educator must have an in-depth understanding of operational requirements related to the management and implementation of a human research protections program with the ability to contribute to planning programmatic improvements including, under the guidance and direction of the Assistant VP of Research Affairs, development of procedures that are comprehensive and practical.
For more information regarding the Division of Research and Innovation, click here.
This is a full-time (1.0 time-base) benefits eligible, permanent (probationary) position. This position is designated exempt under FLSA and is not eligible for overtime compensation. Standard SDSU work hours are Monday - Friday, 8:00 a.m. to 4:30 p.m., but may vary based on operational needs.
Education and Experience
Entry to this classification requires general knowledge and skills in the applicable administrative and/or program field with a foundational knowledge of public administration principles, practices, and methods. This foundation would normally be obtained through a bachelor's degree and/or equivalent training and administrative work experience involving study, analysis, and/or evaluation leading to the development or improvement of administrative policies, procedures, practices, or programs.
Advanced degree preferred.
Certified IRB Professional (CIP) preferred.
Specialized Skills Required
Two years' experience in regulatory compliance at an academic institution with a focus on human subjects' protection with knowledge of federal, state and institutional regulations and policies for human subjects' protections.
Thorough knowledge of policies, procedures, and outside regulations pertaining to human research protections and oversight.
Comprehensive knowledge of federal, state, and local regulations and policies governing human subject research including: The Department of Health and Human Services Office of Human Research Program regulations, Food and Drug Administration regulations for the use of investigational drugs, biologics and devices, California law on human experimentation, and university policy regarding human subjects' research.
Ability to gain and refine detailed knowledge of a substantial body of regulatory information, analyze and synthesize complex concepts, and communicate this information effectively in the compliance monitoring and education process.
Ability to develop, monitor and maintain a comprehensive training program to ensure relevant and up to date content is accessible to students, faculty and staff.
Ability to foster open communications within the institution to enhance ethical and responsible research practices specific to human subjects' protections.
Ability to assess effectiveness of programmatic practices and standards and implement changes as needed.
Ability to enforce standards of compliance and communicate appropriate information to senior management or administrators at other universities, research sponsors and regulatory agencies as needed.
Ability to convey information to investigators that facilitates research and minimizes adversarial approaches to regulatory compliance.
Compensation and Benefits
Starting salary upon appointment not expected to exceed $4,800 per month. CSU Classification Salary Range: $3,897 - $7,051 per month. Salary placement is determined by the education, experience, and qualifications the candidate brings to the position, internal equity, and the hiring department's fiscal resources.
San Diego State University offers a rich benefits package that constitutes a major portion of total compensation. For more information regarding SDSU benefits, please click here.
Review of the required application materials, including cover letters and resumes, began on August 19, 2021. Additional applications will be reviewed upon receipt. This position will remain open until filled.
The person holding this position is considered a mandated reporter' under the California Child Abuse and Neglect Reporting Act and is required to comply with the requirements set forth in CSU Executive Order 1083 as a condition of employment.
San Diego State University is not a sponsoring agency for staff or management positions (e.g., H-1B visa). Applicants must currently be authorized to work in the United States on a full-time basis. Offers of employment are contingent upon the presentation of documents that demonstrate a person's identity and authorization to work in the United States, which are consistent with the provisions of the Immigration Reform and Control Act.
A background check (including a criminal records check) must be completed satisfactorily before any candidate can be offered a position with the CSU. Failure to satisfactorily complete the background check may affect the application status of applicants or continued employment of current CSU employees who apply for the position.
SDSU is a smoke-free campus. For more information, please click here.
SDSU is an equal opportunity employer and does not discriminate against persons on the basis of race, religion, national origin, sexual orientation, gender, gender identity and expression, marital status, age, disability, pregnancy, medical condition, or covered veteran status.
Applicants with disabilities and applicants who require assistance completing an application may contact Meracle Cothron at email@example.com.
Advertised: Oct 28, 2021 (9:00 AM) Applications Close: Open until filled
Founded in 1897, San Diego State University is a public institution of higher education located in southern California. SDSU is the oldest and largest university in San Diego and the third largest in the state. SDSU continues to gain recognition as a leader in higher education.
Join SDSU and make a difference through meaningful work that contributes to knowledge and provides rich opportunities for students. The dynamic synergy between SDSU and the San Diego region furthers SDSU's excellence and global impact. Every member of our team can proudly proclaim, "I Am SDSU."
In addition to SDSU, three not-for-profit auxiliary employers operate to provide services for the University. The SDSU Research Foundation furthers the educational, research and community service mission of SDSU. Aztec Shops provides a diverse portfolio of products and services including operation of the SDSU Bookstore, SDSU Dining, and management of commercial and real estate properties surrounding the campus. Associated Students of SDSU is a student-directed organization that manages programs and facilities enjoyed by students, faculty, staff, and the community-at-large.