DescriptionUniversity of Colorado Anschutz MedicalCampus

Department: ResearchCompliance Office - COMIRB

Job Title: IRB Review Specialist (MultipleOpenings)

Position#708125 – Requisition #17451

 * Applications are acceptedelectronically ONLY at www.cu.edu/cu-careers *

 The University of Colorado Denver l Anschutz Medical Campus seeksindividuals with demonstrated commitment to creating an inclusive learning andworking environment.  We value theability to engage effectively with students, faculty and staff of diversebackgrounds.

 Who We Are:A national leader in health care and life sciences, CU Anschutz is theonly comprehensive academic health sciences center in Colorado and the largestin the Rocky Mountain region. Located in Aurora, Colo., it is one of the newesteducation, research and patient care facilities in the world. With six schoolsand colleges, CU Anschutz trains the health sciences workforce of the future byblending education, research and clinical care all in one place. This strategiccollaboration among diverse health care fields allows knowledge to traveldirectly from the research bench to the patient’s bedside. Read CU Anschutz Quick Facts here.

 The ResearchCompliance Office has multiple openings for full-time University Staff (unclassified) IRB ReviewSpecialist positions.

Jobs in this career family provide direct professional support ofresearch activities.  Functions includecontracts and grants solicitation and administration, grant/agreement preparation,review and negotiation, regulatory compliance, sponsor communication and postand pre award management, human subject compliance, research animal management,research laboratory coordination and instruction, environmental health andsafety, radiation control, hazardous materials use, disposal and training.

 Senior Professionals are responsible for exercising discretion,analytical skill, personal accountability and responsibility in a wide range ofareas including academic, administrative, managerial and student servicesfunctions. Work involves creating, integrating, applying and sharing knowledgedirectly related to a professional field. Work is performed fully independently.

 Department Summary:The Colorado Multiple Institutional Review Board (COMIRB) exists toreview all proposed human research projects prior to implementation in theaffiliated institutions and/or research conducted by faculty or staff membersof these institutions, even if it is performed at other locations.  COMIRB review is performed in accordance withmandated federal regulations.  The mainresponsibilities of the COMIRB office and panels in the order of priorityare:  1) protect human subjects and theirrights, 2) protect researchers, and 3) protect the institution. This is a criticalrole to ensure that COMIRB is fulfilling its mandate of human subjectprotection and maintains compliance with federal regulations.

 Colorado Multiple Institutional Review Board (COMIRB) is the IRB thatserves a consortium of academic and health care facilities in Coloradoconsisting of:

• University of Colorado Denver | Anschutz MedicalCampus
• Denver Health and Hospital Authority
• VA Eastern Colorado Health Care System
• Children's Hospital Colorado
• University of Colorado Health

Job Summary:The IRB Review Specialist facilitates IRB review by providing outreachand consultations for researchers and research staff at the University and ouraffiliates. This position will work directly with researchers to help solveIRB-related issues for new and existing studies, both within the COMIRB officethrough management of the COMIRB Help Desk, and by meeting with theresearchers. This position also provides education and training for researchersand research staff as needed. These responsibilities requires an excellentworking knowledge of human subjects regulations, thorough knowledge ofadditional resources and professional staff available to investigators at theuniversity and our affiliates, and excellent customer services skills.

 This position also serves as an IRB member, designated to review humansubjects research eligible for expedited IRB review, exemption, and fordeterminations of not human subjects research. The research may be biomedicalor social/behavioral in nature, and much of it will be secondary research.These responsibilities require expert understanding of criteria for expeditedreview, exempt research, and the definition of human subjects research.Processing the submissions requires expert understanding of COMIRB businesssystems and policies. This position must professionally and accurately adviseresearchers on and changes that are necessary to conduct their research incompliance with IRB requirements. This position will attend IRB meetings, andprovide support to other COMIRB IRB panels as necessary.

 Facilitate the IRB reliance process when COMIRB is serving as a sIRB.Ensure study documentation is compliant with COMIRB policies and procedures forserving as a sIRB. Meet with researchers and research staff responsible forsIRB submissions and management to help provide training and follow-up support.

 Examples of Work Performed:

• Serve as front line IRB support for researchers andresearch staff at the University and our affiliates. Provide advice on COMIRBpolicies and procedures, and federal requirements for human subjects research.Support the COMIRB Help Desk Meet. Meet in person with researchers and researchteams to help solve IRB-related problems for individual studies, or groups ofstudies.
• Provide on demand IRB-related training forindividual researchers or research teams.
• Work with COMIRB leadership and our regulatorypartners at the University and/or our affiliate institutions to improve andimplement IRB-related business practices.
• Conduct expedited review of eligible research as adesignated IRB member. Process IRB submissions as necessary for COMIRB businesssystems. When appropriate for more complex research or where particularexpertise is needed, assign a faculty IRB member as expedited reviewer.
• Make exempt determinations for qualifying researchproposals. Make determinations of not human subjects research for qualifyingproposals. Process submissions as necessary for COMIRB business systems.
• Attend COMIRB Office Hours on a regular basis.
• Provide scheduled presentations and training asneeded, and lead informational sessions for research faculty and staff, as wellas COMIRB staff.
• Support COMIRB business practices when serving as asIRB.
• Must be able to understand and analyze technicalresearch, medical and legal language, and research concepts, synthesizing theessential points from complex multiple participant discussion.
• Ensure that protocol review documentation complieswith COMIRB policies and procedures, federal regulations, and AAHRPPaccreditation standards. Ensure protocols are reviewed and processed in atimely manner.
• Perform internal quality assurance as directed toensure compliance with OHRP and FDA Regulations for COMIRB panel review anddocumentation.
• Assist with initial and ongoing training ofresearchers and research staff as necessary. Assist in the ongoing training ofCOMIRB staff as necessary.
• Work closely with the Financial Manager to ensurethat invoicing is conducted for appropriate studies.
• Assist with special projects as assigned.

This description is a summary only and is describing the general levelof work being performed, it is not intended to be all-inclusive. The duties ofthis position may change from time to time and/or based on business need. Wereserve the right to add or delete duties and responsibilities at thediscretion of the supervisor and/or hiring authority.

QualificationsMinimum Qualifications:

A bachelor’s degree in public health, public administration, or a directly related field from an accredited institution and 2 years of professional level experience in an academic setting with a minimum of one year’s experience in research or compliance.

Experience working with OHRP/FDA regulations regarding human subject research.

Certified as an IRB Professional. (CIP may be obtained after starting.)

Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis.

Conditions of Employment:

This is full-time position with minimum work hours of 8am-5pm Monday through Friday. 

Preferred Qualifications:

Graduate degree

Experience working with an IRB

Competencies:

Ability to communicate effectively, both in writing and orally.

Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.

Outstanding customer service skills.

Demonstrated commitment and leadership ability to advance diversity and inclusion.

Working knowledge of OHRP and FDA regulations for human subject research

Knowledge of higher educational and/or research environment

Familiarity with research and regulatory infrastructure and professional staff at the University and our affiliate institutions

Ability to communicate effectively both orally and in writing     

Excellent interpersonal and human relations skills

Excellent analytical and problem solving skills

Ability to plan, meet deadlines, work under pressure, and organize multiple projects or tasks

Comprehensive personal computing skills and ability to access complex relational databases

Ability to effectively support the panel team and contribute to working groups, staff meetings, and other committees as assigned

Ability to work independently

Salary and Benefits:

Thesalary range for this full-time position has been established at $51,837 to$55,000 and is commensurate withskills and experience.

Thisposition is not eligible for overtime compensation

Yourtotal compensation goes beyond the number on your paycheck. The University ofColorado provides generous leave, health plans and retirement contributionsthat add to your bottom line.

Benefits: https://www.cu.edu/employee-services/benefits.

Total Compensation Calculator: https://www.cu.edu/employee-services/total-compensation

Diversity and Equity:Pleaseclick here for information on disability accommodations: http://www.ucdenver.edu/about/departments/HR/jobs/Pages/JobsatCUDenver.aspxTheUniversity of Colorado Denver | Anschutz Medical Campus is committed torecruiting and supporting a diverse student body, faculty and administrativestaff. The university strives to promote a culture of inclusiveness, respect,communication and understanding. We encourage applications from women, ethnicminorities, persons with disabilities and all veterans. The University ofColorado is committed to diversity and equality in education and employment.TheUniversity of Colorado Denver | Anschutz Medical Campus is dedicated toensuring a safe and secure environment for our faculty, staff, students andvisitors. To assist in achieving that goal, we conduct backgroundinvestigations for all prospective employees. 

Job Category: Research Services
Primary Location: Aurora
Schedule: Full-time
Posting Date: Oct 8, 2019
Unposting Date: Ongoing