IBC Committee Coordinator

Applications are accepted electronically ONLY at www.cu.edu/cu-careers
University of Colorado Denver/Anschutz Medical Campus
Research Committee Support, Office of Regulatory Compliance
IBC Committee Coordinator
Position Number: 724274
Nature of Work: The CU Denver/Anschutz Medical Campus Office of Regulatory Compliance through the auspices of the Office of Research Committee Support (ORCS) exercises regulatory compliance and compliance oversight for research conducted at CU Denver campuses and off-site laboratories.
This responsibility includes management of research protocol review for the Committees governing the use of animals and biological, chemical or radioactive materials. In this capacity, ORCS provides the administrative support for the Institutional Biosafety Committee (IBC), to assure regulatory compliance and safety oversight for research activities and materials in accordance with applicable Federal, State and local regulations which govern the use of recombinant DNA materials in research.
Professional Field:
The IBC Coordinator oversees the office administration of and work flow for the IBC to ensure that the committee conducts their reviews of submitted protocol applications and provide ongoing monitoring, in accordance with all regulatory requirements, University policies and procedures and any other applicable standards.
The Institutional Biosafety Committee (IBC) is an institutional committee, federally mandated under the NIH Guidelines for Research Involving recombinant DNA Molecules, to review and oversee all research involving recombinant DNA materials, in research laboratories, in tissue culture, animals and/or plants and in human subjects clinical trials.
The IBC is also mandated, on behalf of the University, to review and oversee all research involving Select Agents materials.
The IBC exists to review all proposed research applications (protocols, projects) with recombinant DNA and/or Select Agents, prior to initiation, at the University and its affiliated institutions and/or research conducted by faculty or staff members of the University, even if it is performed at other locations. The IBC research review is performed in accordance with mandated federal regulations.
This is a full-time, University Staff (non-classified) position.
Examples of Work Performed
The Coordinator is responsible for ensuring that the Committee's policies and procedures are consistently applied to all applications (projects, protocols) submitted for review to the Office of Research Committee Support and the IBC.
The Coordinator will work closely with all EHS and Office of Regulatory Compliance staff.
The Coordinator will work closely with IACUC and COMIRB offices to correctly coordinate review and approval of research protocols involving recombinant DNA used in animal or human research (Human Gene Transfer clinical trials).
The Coordinator fields questions from researchers conducting research involving recombinant DNA pertaining to appropriate forms and processes for approval.
The Coordinator manages all administrative aspects of the receipt of incoming applications (protocols, projects) and related documents (amendments, addenda, supporting documents) received by the Biosafety Program in electronic or hard copy format.
The Coordinator checks the Biosafety Program email account daily for incoming application forms and supporting documentation and responses to requests for information from Principal Investigators.
The Coordinator saves all applications and supporting documents as electronic files for internal pre-review by the Biosafety Office.
The Coordinator enters all pertinent data upon receipt of applications, amendments and any other supporting documents in the Biosafety Program MS Access database and the EHS-Assistant database, as necessary.
The Coordinator works with the Biosafety Officer to conduct pre-review of all applications submitted and prioritizes protocols for review at meetings and creates the agenda with the pertinent information.
The Coordinator plans, coordinates, and staffs committee meetings. The Coordinator works with the Biosafety Office, IBC Chair(s) and committee members to develop meeting schedules, arrange meeting rooms and necessary audiovisual or computer support for meetings; prepares the meeting agenda and oversees protocol packet preparation and distribution to Committee members and assures a quorum is available to convene the meeting and conduct committee business.
The Coordinator acts as the recorder for minutes (in addition to using electronic recording equipment) at Committee meetings to ensure that the minutes accurately reflect the meeting content. The Coordinator must be able to understand and transcribe upper level technical, medical and legal language, and research concepts.
The Coordinator transcribes handwritten notes, email reviews/comments from Committee members and the electronic recordings to prepare draft meeting minutes for review by the committee. The Coordinator corrects or amends draft documents to ensure that the minutes accurately reflect the meeting content and ensures that minutes comply with federal standards.
The Coordinator also enter results of deliberations, and voting on applications, at convened meetings into the appropriate databases.
The Coordinator is also an important resource to faculty and research staff who have committee process-related questions to be addressed. S/he works on with the IBC on the drafting, development and publication of committee policies and administrative procedures as well as assisting in the development of the committee website.
The Coordinator performs internal office audits to ensure the proper maintenance and accuracy of protocol files and data entry according to federal regulatory requirements and Committee administration SOPs or guidelines to ensure the timeliness, correctness and compliance of reviews conducted by the respective committees.
Manage ongoing maintenance of IBC panel system, including testing of fixes and upgrades.
Serve as the liaison between business owners, departmental users and Research Information Technology (RIT).
Record and track all issues that arise during implementation or post-production and facilitate discussions with support to work out resolutions to issues that cannot be addressed through system configuration or business process
Supervision Received: The IBC Committee Coordinator will report to the Director, ORCS.
Supervision Exercised:
The Committee Coordinator will not directly supervise any staff. The incumbent will need to work closely with the Director, ORCS, as well as the Biosafety Officer and staff to ensure that there is an effective work flow across the Department, with subject matter experts, with the Committee members and with the Office of Regulatory Compliance and other senior administration offices. The Coordinator will also work closely with IACUC and COMIRB offices to correctly coordinate review and approval of research protocols involving recombinant DNA used in animal or human research (Human Gene Transfer clinical trials). The Coordinator will also provide guidance and information to Principal Investigators and researchers pertaining to the administrative processes for approval.
Salary and Benefits:
The hiring salary for this position is $36,975 - $50,000 and is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation.
The University of Colorado offers a full benefits package. Information on University benefits programs, including eligibility, is located at https://www.cu.edu/employee-services .
The University of Colorado Denver/Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees.
The University of Colorado Denver/Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
Qualifications:
Minimum Requirements:
? Bachelor's degree in a related field (or equivalent experience).
? Experience in an academic setting, with a minimum of two years' experience in managing research studies.
+ Combination of education and experience can substitute for bachelor's degree.
Preferred Requirements:
? Experience working with NIH Guidelines for Research Involving recombinant DNA Molecules.
? Experience working with AWA/PHS (OLAW) regulations regarding animal subject research.
? Experience working with FDA/OHRP regulations regarding human subject research.
Competencies/Knowledge, Skills, and Abilities:
? Working knowledge of NIH Guidelines for Research Involving recombinant DNA Molecules.
? Knowledge of higher educational and/or the research environment.
? Ability to communicate effectively both in writing and orally.
? Strong interpersonal and human relations skills.
? Strong analytical and problem solving skills.
? Ability to plan, organize and meet deadlines, work under pressure, and organize multiple projects or tasks.
? Comprehensive personal computing skills and ability to manage information in complex relational databases.
? Ability to troubleshoot systems with documentation and beyond documentation, persisting until a fix is complete
? Self-motivated and proactive, taking initiative to solve problems and recruit assistance for those solutions quickly
? Ability to effectively support the Committee, Chair(s), investigators, and contribute to working groups, staff meetings, and other committees as assigned
? Required ability to communicate effectively in writing and orally, strong interpersonal skills and human relation skills, and an ability to effectively prepare and coordinate meetings.
? General familiarity with relational database design, structure and maintenance
Special Instructions to Applicants: Applications are accepted electronically ONLY at www.cu.edu/cu-careers.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:Applications will be accepted until the position is filled. f1c3a60789fa40fab1e015d0b41fc23a

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