Human And Animal Protections

Working Title

Human and Animal Protections (HAP) Administrator (Administrative Analyst/Specialist, Exempt III) - Office of Research and Sponsored Programs

SF State University

San Francisco State is an Equal Opportunity Employer and does not discriminate against persons on the basis of race, religion, color, ancestry, age, disability, genetic information, gender, gender identity, gender expression, marital status, medical condition, National origin, sex, sexual orientation, covered veteran status, or any other protected status. Reasonable accommodations will be provided for qualified applicants with disabilities who self-disclose by contacting the Senior Human Resources Manager.
Applicants may visit titleix.sfsu.edu for more information on SF State's policy prohibiting discrimination, and how to file an online report using the procedures under Executive Order 1096 Revised. Inquiries can be directed to the campus Title IX Coordinator and Discrimination, Harassment, and Retaliation Administrator by calling (415) 338-2032 or emailing [email protected].
San Francisco State is a 100% Smoke/Vapor-Free Campus. Smoking or Vaping of any tobacco/plant-based substance is not permitted on any University properties.
The person holding this position may be 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.
This position may be a "designated position" in the California State University's Conflict of Interest Code. The successful candidate accepting this position may be required to file Conflict of Interest forms subject to the regulations of the Fair Political Practices Commission.

Department

Office of Research & Sponsored Programs

Appointment Type

Probationary

Time Base

1.0

Work Schedule

Monday - Friday; 8:00AM - 5:00PM

Anticipated Hiring Range

$7,667.00 - $8,083.00 per month ($92,004.00 - $96,996.00 Annually)

Salary is commensurate with experience.

Position Summary

The Human and Animal Protections (HAP) Administrator is an administrative leadership position in the Office of Research and Sponsored Programs (ORSP) responsible for oversight of the HAP unit. This position provides broad oversight and ensures compliance with Federal, State, CSU and campus policies and procedures. The successful candidate will provide administrative, analytic and systems oversight to ensure that Human and Animal Subjects compliance criteria are met.

Under general direction of the AVP Research and Sponsored Programs (Institutional Official) and the Director of the Office of Research and Sponsored Programs, the incumbent provides leadership for the day to day operation of the Human and Animal Protections Unit. The HAP Administrator assesses, formulates, and evaluates the impact of policies from a strategic and operational perspective. This position will regularly participate in planning and development activities and, as required, independent determination of methods to meet the administrative goals of the IRB and IACUC.

The HAP Administrator is responsible for the review, analysis and evaluation of human and animal research protocols and works alongside the committee chairs and members; organizes and runs the monthly review committee meetings; communicates recommendations and approvals to student and faculty investigators; provides technical and analytical recommendations as they relate to and enhance office operations; updates, maintains, compiles and prepares database reports; provides one-on-one assistance in creating and revising protocols; supervises student assistants and staff; streamlines existing and develops new policies and procedures and conducts outreach and training presentations.

Position Information

• Demonstrate safe work practices for oneself, others and the office environment
• Ensure full compliance with all local, state and federal regulations regarding the protection of human subjects and animals involved in research and that practices and procedures are consistent with the Federal Wide Assurance (FWA) accepted by DHHS and OLAW. Participate and represent ORSP in audits and inspections by federal or state regulators (FDA, USDA, NIH, CSU auditors). Interact and network with staff from other IRB/IACUCs, as well as professional organizations
• Oversee web site content and ensure that the information provided is current
• Serve as primary contact for researchers; assist with issues related to the preparation and submission of IACUC and IRB protocols and provide preliminary review of submitted protocols for completeness and accuracy; review protocols and directs exempt and expedited protocol to the Chair for review and approval
• Assist with special initiatives and projects as needed Other duties as assigned
• Demonstrated behaviors that are in line with the User Friendly Principles(P530C) and Principles of Conduct for a Multi-Cultural University (P30D)
• Develop training materials and organize training sessions related to human and animal subject research for faculty and students, including classroom presentations and outreach activities
• Identify policy issues that need clarification by committee; research and provide material to committee(s) to make decisions, for example recent legislative activity, current journal articles, other IRB policies
• At all times:
• Recruit new IRB and IACUC members, provide training for new and current members, ensure that membership meets federal guidelines, and ensure quorum for protocol review at all meetings. Coordinate meetings that take place outside of the academic year
• Streamline existing / develop new HAP policies and procedures and oversee the implementation of an online protocol submission process for research involving human subjects. Develop training programs for faculty, students and approvers
• Prepare draft reports to Federal agencies as required; maintain detailed records on all regulatory compliance related responsibilities; Update regulatory information and registration for IRB and IACUC
• Provide lead work direction and oversight of the staff on the team
• In coordination with IRB and IACUC Chairs, develop committee meeting agendas and materials, prepare meeting minutes and provide regulatory guidance as needed at meetings
• Coordinate with other units on campus (ie. Environmental Health and Safety, Risk Management) and consultants (Occupation Health) to ensure compliance with all local, state and federal regulations regarding the protection of human subjects and animals involved in research

Minimum Qualifications

• Ability to understand and analyze complex problems from a future-oriented and broad interactive perspective and readily develop proactive solutions that integrate strategic goals into tactical operations.
• Ability to effectively use all communication methods and formats and to use expertise, as well as persuasion and negotiation skills, to build consensus to achieve short- and long-term goals and objectives
• Extensive and in-depth knowledge of and ability to apply expertise in the advanced theories, principles, methods and practices associated with the functional specialty, program, and/or organizational unit, including applicable internal policies and procedures and pertinent laws and regulations. Laws and regulations are highly complex and require substantial judgment and discretion in interpreting and applying them to the specialty or program area. Incumbents at this level often may have certification in a specialty area.
• Substantial and broad knowledge of public and private entities including their organizational and operating structures, internal systems, and functional areas, as well as the impact of critical external entities on an organization. Ability to integrate and apply this knowledge to anticipate problems and assess the impact of proposed solutions on various organizational areas.
• 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.
• Extensive and in-depth knowledge in project management including research and analytical methodologies. Ability to interpret and integrate complex data and information to formulate appropriate courses of action which have broad and far reaching impact.
• Ability to effectively use applicable information systems and applications in analysis, research, and reporting activities and projects.
• Ability to effectively communicate with and influence high-level and diverse contacts inside and outside of the CSU system.

Preferred Qualifications

Education: Bachelor’s degree required, an advanced degree in a related field, or equivalent industry experience.

Certification: CIP-Certified IRB Administrator and/or CPIA-Certified Professional IACUC Administrator, or willingness to complete the certification process for both.

Work Experience: Training and administrative work experience in the administrative functions supporting IRB and IACUC administration with foundational knowledge of public administration principles/practices/methods, involving study, analysis, and/or evaluation leading to the development or improvement of administrative policies, procedures, practices, or programs, including experience working successfully as a team member. Experience with human and animal subjects protocol review; and experience working with faculty and students about research; understanding of Federal, State and University policies and regulations regarding the use of human and animals in research.

Knowledge: working knowledge of general practices, program, and/or administrative specialty; basic knowledge of and ability to apply fundamental concepts; working knowledge of university policies and procedures; methods and procedures for research and statistical analysis and the ability to apply them.

• Three or more years of experience working on or with an IRB, or equivalent industry experience
• Excellent interpersonal skills to deal effectively with researchers, facility workers, administration and management, outside contractors, and governmental agencies.
• High-level computer skills for document preparation, database management, software implementation and presentations.
• Excellent verbal/written and interpersonal/communication skills to correspond with students, faculty, administrators and other departments; possess organizational skills; experience/knowledge/use of MS Office and databases.
• Three or more years of experience working on or with an IACUC, or equivalent industry experience.
• Skills in developing and implementing policies and training programs for human subjects research
• Skills in developing and implementing policies and training programs for laboratory animal care and use.
• Ability to effectively balance multiple schedules and demands and meet critical deadlines. Ability to exercise initiative and appropriate independent judgment in performance of assigned tasks.

Specialized Knowledge: Knowledge and understanding of:

• USDA Animal Care and Animal Welfare Act regulations
• 45 CFR 46 and DHHS Policy for the Protection of Human Research Subjects
• NRC "Guide for the Care and Use of Laboratory Animals"
• Standards of excellence necessary for obtaining and maintaining full accreditation status with the Association for Assessment and Accreditation of Laboratory Animal Care
• Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals

Abilities: learn/interpret/apply a wide variety of policies and procedures relating to and impacting the organizational unit, and/or administrative specialty; organize/plan work and projects including handling multiple priorities; make independent decisions and exercise sound judgment; compile/compose/present reports; demonstrated ability to establish/maintain effective working relationships within/outside the work group; serve as a liaison for the organizational unit.

Specialized Abilities: analyze situations independently to determine when consultation is necessary; track large numbers of protocols and related documents through the review, revision and approval process for human subjects research; work independently; review/interpret/analyze protocols and make appropriate determinations; recognize when to consult supervisors; excellent organizational skills; compose organized, highly detailed correspondence to students and faculty; recommend specific protocol revisions towards achieving IRB (Institutional Review Board) or IACUC approval.

Thorough knowledge of and ability to apply extensive expertise to complex programs and/or administrative specialties, including pertinent laws and regulations related to Human and Animal Protections.

• Ability to effectively present ideas and concepts in written or presentation format and use consultative and facilitation skills to gain consensus.
• Ability to work with representatives from public and private entities and handle potentially sensitive situations.
• Demonstrated consultative skills in working with internal and external constituent groups.
• Expertise in administrative survey techniques, operations and systems analysis, statistical and research methods, and the ability to interpret and evaluate results to develop sound conclusions and recommend new or revised policies.
• Ability to understand problems from a broad, interactive perspective and discern applicable underlying principles to conceive of and develop strategic solutions.
• Demonstrated expertise in and advanced knowledge of the principles, problems, and methods of public and business administration and operational and fiscal management.

Core Competencies:

• Customer/Client Focus with an emphasis in problem solving and resolution
• Personal effectiveness as demonstrated by interpersonal and professional confidence
• Effective oral, written and nonverbal communication skills
• Bias toward collaboration and teamwork
• Diversity and inclusion

Required License/Certification

• Completed the Human Participants Protection Education for Research Teams online course, sponsored by the NIH.
• Completed the Collaborative Institutional Training Initiative (CITI) online course for working with human volunteers in research.
• CIP-Certified IRB Administrator and/or CPIA-Certified Professional IACUC Administrator or, or willingness to complete the certification process for both certifications.
• Completed the CITI online course for working with animal subjects in research.

Pre-Employment Requirements

This position requires the successful completion of a background check.

Eligibility to Work

Applicants must be able to provide proof of US Citizenship or authorization to work in the United States, within three business days from their date of hire.

Benefits

Threaded through our Total Compensation package is a commitment to Bridging Life's Transitions. SF State is committed to providing our employees with a comprehensive program that rewards efforts that are appreciated by your colleagues, students and the customers we serve.
We offer a competitive compensation package that includes Medical, Dental, Vision, Pension, 401k, Healthcare Savings Account, Life Insurance, Disability Insurance, Vacation and Sick Leave as well as State Holidays and a dynamic Fee Waiver program, all geared towards the University's commitment to attract, motivate and retain our employee.

CSUEU Position

Eligible and qualified on-campus applicants, currently in bargaining units 2, 5, 7, and 9 are given hiring preference.

Additional Information

SF STATE IS NOT A SPONSORING AGENCY FOR STAFF OR MANAGEMENT POSITIONS. (i.e. H1-B VISAS).
The Human Resources office is open Mondays through Fridays from 8 a.m. to 5 p.m., and can be reached at (415) 338-1872.

Please note that this position, position requirements, application deadline and/or any other component of this position is subject to change or cancellation at any time.