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University of Colorado IRB Review Specialist in Aurora, Colorado

Description

University of Colorado | CU Anschutz Medical Campus

Department: Research Compliance Office - COMIRB

Job Title: IRB Review Specialist

Position #708125 – Requisition #19721

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

  • The University of Colorado Anschutz Medical Campus seeks individuals with demonstrated commitment to creating an inclusive learning and working environment. We value the ability to engage effectively with students, faculty and staff of diverse backgrounds.

Who We Are:

The University of Colorado Anschutz Medical Campus is a public education, clinical and research facility serving 4,500 students, and a world-class medical destination at the forefront of life-changing science, medicine, and healthcare. CU Anschutz offers more than 42 highly rated degree programs through 6 schools and colleges, and receives over $500 million in research awards each year. We are the single largest health professions education provider in Colorado, awarding nearly 1,450 degrees annually. Powered by our award-winning faculty, renowned researchers and a reputation for academic excellence, the CU Anschutz Medical Campus drives innovation from the classroom to the laboratory to the delivery of unparalleled patient care. Read CU Anschutz Quick Facts here. (https://www.cuanschutz.edu/docs/librariesprovider15/default-document-library/2019-facts-brochure_web.pdf)

Department Summary:

The Colorado Multiple Institutional Review Board (COMIRB) exists to review all proposed human research projects prior to implementation in the affiliated institutions and/or research conducted by faculty or staff members of these institutions, even if it is performed at other locations. COMIRB review is performed in accordance with mandated federal regulations. The main responsibilities of the COMIRB office and panels in the order of priority are: 1) protect human subjects and their rights, 2) protect researchers, and 3) protect the institution. This is a critical role to ensure that COMIRB is fulfilling its mandate of human subject protection and maintains compliance with federal regulations.

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

  • University of Colorado Denver | Anschutz Medical Campus

  • Denver Health and Hospital Authority

  • VA Eastern Colorado Health Care System

  • Children's Hospital Colorado

  • University of Colorado Health

COMIRB has an opening for a full-time University Staff (unclassified) IRB Review Specialist position.

Jobs in this career family provide direct professional support of research activities. Functions include contracts and grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, 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 of areas including academic, administrative, managerial and student services functions. Work involves creating, integrating, applying and sharing knowledge directly related to a professional field. Work is performed fully independently.

Job Summary:

This IRB Review Specialist position facilitates IRB review by providing outreach and consultations for researchers and research staff at the University and our affiliates. This position will work directly with researchers to help solve IRB-related issues for new and existing studies, both within the COMIRB office through management of the COMIRB Help Desk, and by meeting with the researchers. This position also provides education and training for researchers and research staff as needed. These responsibilities require an excellent working knowledge of human subjects regulations, thorough knowledge of additional resources and professional staff available to investigators at the university and our affiliates, and excellent customer services skills.

This position also serves as an IRB member, designated to review human subjects research eligible for expedited IRB review, exemption, and for determinations of not human subjects research. The research may be biomedical or social/behavioral in nature, and much of it will be secondary research. These responsibilities require expert understanding of criteria for expedited review, exempt research, and the definition of human subjects research. Processing the submissions requires expert understanding of COMIRB business systems and policies. This position must professionally and accurately advise researchers on and changes that are necessary to conduct their research in compliance with IRB requirements.

In addition this position will; attend IRB meetings, provide support to other COMIRB IRB panels as necessary, facilitate the IRB reliance process when COMIRB is serving as a a sIRB, ensure study documentation is compliant with COMIRB policies and procedures for serving as a sIRB, meet with researchers and research staff responsible for sIRB submissions and management to help provide training and follow-up support.

Examples of Work Performed:

Specific responsibilities include but are not limited to:

  • Serve as front line IRB support for researchers and research staff at the University and our affiliates. Provide advice on COMIRB policies and procedures, and federal requirements for human subjects research. Support the COMIRB Help Desk Meet. Meet in person with researchers and research teams to help solve IRB-related problems for individual studies, or groups of studies.

  • Provide on demand IRB-related training for individual researchers or research teams.

  • Work with COMIRB leadership and our regulatory partners at the University and/or our affiliate institutions to improve and implement IRB-related business practices.

  • Conduct expedited review of eligible research as a designated IRB member. Process IRB submissions as necessary for COMIRB business systems. When appropriate for more complex research or where particular expertise is needed, assign a faculty IRB member as expedited reviewer.

  • Make exempt determinations for qualifying research proposals. Make determinations of not human subjects research for qualifying proposals. Process submissions as necessary for COMIRB business systems.

  • Attend COMIRB Office Hours on a regular basis.

  • Provide scheduled presentations and training as needed, and lead informational sessions for research faculty and staff, as well as COMIRB staff.

  • Support COMIRB business practices when serving as a sIRB.

  • Must be able to understand and analyze technical research, medical and legal language, and research concepts, synthesizing the essential points from complex multiple participant discussion.

  • Ensure that protocol review documentation complies with COMIRB policies and procedures, federal regulations, and AAHRPP accreditation standards. Ensure protocols are reviewed and processed in a timely manner.

  • Perform internal quality assurance as directed to ensure compliance with OHRP and FDA Regulations for COMIRB panel review and documentation.

  • Assist with initial and ongoing training of researchers and research staff as necessary. Assist in the ongoing training of COMIRB staff as necessary.

  • Work closely with the Financial Manager to ensure that invoicing is conducted for appropriate studies.

  • Assist with special projects as assigned

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

Salary and Benefits:

  • The starting salary range has been established as $51,564 - $55,000

  • This position is not eligible for overtime compensation

  • Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

  • Here is a link to an overview of the benefits package (https://www.cu.edu/employee-services/benefits-wellness)

  • Here is a link to a Total Compensation Calculator (https://www.cu.edu/node/153125)

Diversity and Equity:

  • The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu

  • 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.

  • 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.

Qualifications

Minimum Qualifications:

  • A bachelor’s degree in public health, public administration, or a directly related field from an accredited institution

  • At least two (2) years of professional level experience in an academic setting with a minimum of one (1) year of experience in research or compliance

  • 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:

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

  • A graduate degree in public health, public administration, or a directly related field from an accredited institution

  • Experience working with an IRB

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

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

Job: Research Services

Primary Location: Aurora

Job Category Research Services

Department U0001 -- DENVER & ANSCHUTZ MED CAMPUS

Schedule Full-time

Posting Date Jan 4, 2021

Unposting Date Ongoing

Posting Contact Name Melissa Smith

Posting Contact Email Melissa.Smith@cuanschutz.edu

Posting Number 00708125

Req ID: 19721

The University of Colorado does not discriminate on the basis of race, color, national origin, sex, age, pregnancy, disability, creed, religion, sexual orientation, gender identity, gender expression, veteran status, political affiliation, or political philosophy. All qualified individuals are encouraged to apply.

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