IRB Review Specialist (Multiple Openings)
DescriptionUniversity of Colorado Anschutz MedicalCampusDepartment: ResearchCompliance Office - COMIRBJob 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
- 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.
Job Category: Research Services
Primary Location: Aurora
Posting Date: Oct 8, 2019
Unposting Date: Ongoing