Senior IRB Specialist
University of Colorado Denver l Anschutz Medical Campus
Colorado Multiple Institutional Review Board
Office of Regulatory Compliance
Job Title: Senior IRB Specialist
Position #687148 - Requisition #12956
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
The University of Colorado Denver l 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 Denver | Anschutz Medical Campus is a public research university serving more than 18,000 students. We award nearly 4,000 degrees each year, including more graduate and professional degrees than any other Colorado institution. With our solid academic reputation, award-winning faculty and renowned researchers, we offer more than 140 highly rated degree programs through 13 schools and colleges. The university receives over $400 million in research awards each year. In addition to the wide array of health-related programs and facilities offered at CU Anschutz in Aurora, Colo. a significant number of undergraduate and graduate degree programs are taught at CU Denver, our comprehensive campus in the heart of downtown Denver-one of America's most vibrant urban centers. CU Denver is located steps from the Denver Center for Performing Arts and the LoDo District affording our students, faculty and staff access to a broad array of academic, professional, community, recreational and cultural outlets. Read more about us here.
Colorado Multiple Institutional Review Board (COMIRB) has an opening for a full-time University Staff (unclassified) Senior IRB 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.
Principal 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 at an advanced or expert level. Principal Professionals are either work leads over others or are considered a subject matter expert in a particular area.
COMIRB reviews proposed human subject 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 panel 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.
Examples of Work Performed:
- This position oversees and facilitates key operations of the protocol review process within the COMIRB office and to ensure that policy and procedures are implemented and consistently applied to AAHRPP accreditation standards within the COMIRB office and at COMIRB panel meetings.
- Coordinate, and provide regulatory support for, processing of new protocols, protocols for continuing review, amendments, unanticipated problem reports, and any other related documents.
- Write and perform detailed review of reports from panel-specific Institutional Review Board (IRB) meetings.
- Perform quality assurance to ensure compliance with Office for Human Research Protection (OHRP) and Food and Drug Administration (FDA) Regulations for COMIRB panel review and office documentation processes.
- Coordinate office-wide training to ensure consistency across Panels by developing education policy and procedures. Develop and conduct training of the IRB panel coordinators and administrative staff to ensure consistent, compliant, and efficient performance of panel coordinators and administrative staff.
- Develop and implement Quality Assurance/Quality Improvement (QA/QI) initiatives to evaluate and improve COMIRB office education and training. Develop and implement QA/QI initiatives to evaluate adherence to COMIRB policy and procedures.
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.
What we require:
- A bachelor's degree in business, administration, scientific field, or a directly related field from an accredited institution
- Experience in an academic setting, with a minimum of two years of experience in research or compliance
- Experience working with OHRP/FDA regulations regarding human subject research
- The position requires extensive, diverse and progressively responsible experience, including direct responsibility for working with OHRP/FDA regulations regarding human subject research
- Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis
- Certification as an IRB Professional Experience with developing and implementing Quality Assurance/Quality Improvement (QA/QI) initiatives Experience working with an IRB
- 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
- Knowledge of principles of ethical conduct of research with human subjects
- Knowledge of clinical research, in particular, clinical research review
- Knowledge of applicable federal regulations (OHRP, FDA, VA, and other government agencies) related to human research subjects protections
- Excellent management and leadership skills
- Ability to communicate and work with diverse individuals in a professional setting
- Excellent written and oral communications skills
- Excellent analytical and time management skills
- Ability to edit and write clear, precise, and grammatically correct minutes
- Ability to work well both independently and with teams
- Ability to succeed in a high volume, time sensitive work environment
- Strong interpersonal and human relation skills
- Ability to ensure compliance with federal regulations and accreditation standards
- The hiring salary for this position has been established at $58,463 and is commensurate with skills and experience
- 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.
Special Instructions to Applicants:Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Review of applications will begin immediately and will continue until the position is filled.
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.
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references)
Job Category: Research Services
Primary Location: Aurora
Department: U0001 -- Denver-Anschutz Administration - 60068 - ADM-VCR COMIRB
Posting Date: Mar 23, 2018
Closing Date: Ongoing
Posting Contact Name: Cat Sutherland
Posting Contact Email: [email protected]
Position Number: 00687148