| Administrative Analyst/Specialist Exempt II, Graduate and Research Affairs -- San Diego, CA |
Author: Amy McDaniel
Date: 11-04-11 16:20
Job Announcement
Job ID: 2191
Location: San Diego Main Campus
Full/Part Time: Full-Time
Regular/Temporary: Temporary
Position Information
Full-time, temporary position anticipated to end on or before six months and one day from the initial date of appointment with the possibility for reappointment and/or permanency.
The Coordinator of the Human Research Protection Program (HRPP) will oversee human subjects research activities conducted under the Federal Wide Assurance of SDSU. This position will ensure the appropriate level of ongoing education and training in regulatory compliance issues including the ethical principles and practices of human subject research and will also be involved in general support of IRB administrative operations. As the primary liaison from the HRPP to the campus, significant contact with the SDSU research community is expected. Will manage relationships with outside entities or agencies and manage sensitive information and situations and contribute to the completion of broader and more complex organizational or program projects and goals. Will provide project leadership and represents the work unit on key projects within and outside the organization. Independent performance of varied or specialized administrative and analytical duties and/or service as a program administrator. Work is reviewed against goals and involves independently planning and performing research and participating in the development, alteration, implementation, and evaluation of the HRPP¿s policies and procedures. Responsibilities include providing guidance on policy and review requirements to faculty and students conducting research with human subjects, guidance in research protocol developments, conducting preliminary review of protocol applications to identify problems and issues that may prohibit a complete review or compromise regulatory compliance, composing clear and concise written correspondence, maintaining records and generating reports. This position will be responsible for the preliminary review of protocol modifications, continuations, and adverse event reports and will facilitate the preparation of agenda materials and minutes of convened committee meetings in accordance with federal requirements. The coordinator will work with investigators throughout the application process as a resource of ethical research practices and federal, state & institutional practices. The coordinator will develop methods to enhance communication with investigators, administrators and staff, and serve as a liaison to technical staff for purposes related to the IRB information and web-based systems. The coordinator will lead the analysts in carrying out the tasks of the Human Research Protection Program and will be responsible for day to day oversight, with the expectation of accountability. It is expected that effective management of day-to-day operations will allow additional time to focus on programmatic enhancements and overall operational improvements. These will include 1- design and implementation of program evaluation -both internal (e.g., review activity by analysts and IRB members) and external (e.g., protocol development, implementation and compliance); 2- improved methods to educate the research community on regulatory and ethical aspects of human research protections, and 3- serving as the contact person for external agencies at local, state and federal levels.
Salary Range
Salary Range: $4,631 - $6,946 per month (Anticipated Hiring Salary Range: $4,631 - $4,792 per month). The competitive salary offered to the selected candidate is determined by the education, experience, and qualifications the candidate brings to the position, internal equity, and the hiring department's fiscal resources.
Responsibilities
The Administrative Analyst/Specialist is responsible for, but not limited to, the following: interpreting and disseminating federal regulations and guidance pertaining to human subjects research in which SDSU is engaged; developing, maintaining and implementing standards responsive to SDSU¿s Federal Wide Assurance of Compliance, other state and/or federal requirements; accepting ethical practices in the review and approval of human subjects research; reviewing proposed changes to federal and state regulations affecting the participation of human subjects in research; following national dialogue and preparing forthcoming regulations by working with the Director, the analysts, and the IRB chair on related campus position and policy; serving as the primary point of contact for the HRPP, and managing relationships with outside entities or agencies; bearing primary responsibility for managing sensitive information and situations; providing guidance to faculty, students, and staff to improve understanding of ethical aspects of human subjects protections and appropriate application of federal regulations; consulting with other CSU campuses on developing procedures for IRB review and oversight; developing, implementing and updating educational outreach programs focused on human subject protection regulations and policies; developing and overseeing training and education used to promote awareness, communication, and understanding of the human subjects research regulations, ethical practices, and the institutional review process (this training occurs through personal contact, written communication, a web based tutorial, departmental lectures, and an occasional seminar series. Recipients of training include staff, IRB members, students and faculty); assigning other analysts to education and training appointments with campus departments/ faculty/ students; overseeing day-to-day HRPP and IRB operations and provides lead work direction to the three analysts, with accountability for results; serving as the primary point of contact for communication to outside local, state and federal agencies as well as collaborating with academic and/or other research institutes regarding details of specific research projects at SDSU; facilitating updates of the SDSU website to provide information regarding the application of regulations to research; collecting data and conduct analyses to inform program improvements to include web updates, development of documents or practices to improve operations, providing overall program leadership.
Knowledge, Skills & Abilities
The ideal candidate will possess working knowledge of and ability to apply standard theories, principles, practices, and techniques applicable to the HRPP to develop conclusions and make recommendations; policies, procedures, and outside regulations pertaining to human research protections and oversight; operational and fiscal analysis and techniques. Ability to take initiative and independently plan, organize, coordinate, and perform work in various situations where numerous and diverse demands are involved; anticipate problems and address them proactively; handle potentially sensitive situations, and to use consultative and facilitation skills to gain consensus; effectively interpret, organize, and present information and ideas in written or presentation form; train others on new skills and procedures; accountable for own work results which are reviewed for soundness of judgment; exercise considerable judgment and discretion reflective of a thorough knowledge of a professional administrative specialty and/or program and/or policy areas need to be exercised; analyze and address problems using reasoning and the interpretation and application of theories and principles to develop and recommend alternatives and best courses of action; coordinate with individuals at all levels within the organization and as needed, acts as a representative to outside entities. Ingenuity in determining methods to achieve programmatic goals and develop and implement program policies required. Skill in the research, development and evaluation of policies and programs, including skill in the collection, evaluation, and interpretation of data to develop sound conclusions and make appropriate recommendations. Expertise in investigating and analyzing problems with a broad administrative impact and implications.
Experience and Education
Bachelor's degree and/or equivalent training and administrative work experience involving study, analysis, and/or evaluation leading to the development of improvement of administrative policies, procedures, practices, or programs. Five years of experience in regulatory compliance at an academic institution with a focus on human subjects protection or other similar, relevant experience.
Specialized Requirements
Experience in development and implementation of education/training materials. Excellent organizational, administrative, and leadership skills; exceptional interpersonal skills to manage and lead a human research protection program; excellent oral and written communication skills; exceptional skills in establishing and maintaining effective working relationships with students, faculty and administrators. Proficiency in understanding and applying complex federal, state and local regulations and developing institutional policy that support regulatory compliance and facilitate research. Knowledge and understanding of legislation, regulations, policies, procedures and ethical issues concerning the protection of research subjects. The 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; develop, monitor and maintain a comprehensive training program to ensure relevant and up to date content is accessible to students, faculty and staff; foster open communications within the institution to enhance ethical and responsible research practices specific to human subjects protections; enforce standards of compliance and communicate appropriate information to faculty, students, and senior management as needed; and to assess effectiveness of programmatic practices and standards and implement changes as needed.
Preferred Qualifications
One year supervisory and/or lead experience. Certified IRB professional (CIP).
Application Procedures
Review of applications will begin on Thursday, November 17, 2011; position will remain open until filled. The on-line application should be completed in detail. COMPLETION OF THE ONLINE APPLICATION IS REQUIRED FOR CONSIDERATION, A RESUME ALONE WILL NOT SUFFICE.
To apply for this position Online, please go to http://hr.sdsu.edu/employment/staffjobs.htm and click on "New & Returning Applicants" under Staff & Management Employment Opportunities". The Job ID number is 2191. Follow the instructions online to submit your application. If you need assistance completing your application there are instructions available on line at http://hr/employment/staffjobs.htm. Applicants with disabilities requiring special attention and/or interview arrangements may call (619)594-7099.
Equal Employment Opportunity
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.
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