Senior IRB Specialist

Applications are accepted electronically ONLY .
University of Colorado Denver l Anschutz Medical Campus
Colorado Multiple Institutional Review Board (COMIRB)
Office of Regulatory Compliance
Job Title: Senior IRB Specialist
Position Number: 656986, Requisition (06491)
This position exists to oversee and facilitate key operations of the protocol review process within the Colorado Multiple Institutional Review Board (COMIRB) office and to ensure that policy and procedures are implemented and consistently applied to accreditation standard within the COMIRB office and at each COMIRB panel meeting. This position will particularly focus to ensure that the pediatric panels are consistent in their approach to the regulations and UCD policies.
COMIRB is the IRB for a number of health care facilities in Colorado consisting of: University of Colorado Denver, Denver Health Medical Center, Denver Veterans Affairs Medical Center, Children's Hospital Colorado, and University of Colorado Hospital.
COMIRB exists to review all proposed human research projects prior to implementation at UCD or the affiliated institutions and/or research conducted by faculty or staff members or students 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.
This is a full-time position with minimum work hours of 8-5 Monday through Friday.
Examples of Work Performed:
? The Senior IRB Specialist is responsible for ensuring that the federal regulations, COMIRB policies and procedures and accreditation standards are consistently applies within the COMIRB office and across the IRB panels.
? Work with the Director to develop processes, policies and procedures to ensure the smooth work flow, timeliness and compliance of COMIRB review of research protocols with a focus on pediatric research.
? Specifically coordinate the COMIRB office processing of new protocols, protocols for continuing review and any other related documents as well as preparation of minutes from panel meetings.
? Develop a quality assurance program to ensure compliance with Federal Regulations and FDA Regulations for COMIRB panel review and COMIRB office documentation processes. Use these tools to monitor the timeliness, correctness and compliance of the review process.
? Be responsible for the initial and on-going training of the IRB Coordinators and Regulatory Analysts.
? Maintain professional communication with principal investigators, coordinators and other research staff, panel chairs, assistant director, administrative assistants, regulatory analysts and panel coordinators for each COMIRB panel to ensure the smooth progress of research studies involving human subjects ? ? ? Be responsible for the training of panel members and ensure that all members meet annual training requirements
? Assist the Director/Assistant Director with special projects as assigned
Salary and Benefits:
The hiring range for this position is $58,410 to $60,600 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
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.
Minimum Qualifications:
1. Bachelor's degree in business, public administration, or closely related field.
2. Experience in an academic setting, with a minimum of two years' experience in research or compliance.
3. Experience working with FDA/OHRP regulations regarding human subject research with specific expertise in regulations and ethical issues concerning pediatric research.
Substitutions: Professional experience working with Institutional Review Boards or in research studies will substitute for the bachelor's degree on a year-for-year basis.
A master's degree in business, public administration, or closely related field will substitute for the bachelor's degree.
Preferred Qualifications:
1. Certification as an IRB Professional
2. Experience developing and supervising IRB process
3. Healthcare qualification such as Registered Nurse or Nurse Practitioner is desirable, preferably with an emphasis in pediatrics.
4. Experience supervising personnel.
Competencies/Knowledge, Skills, and Abilities:
? Knowledge of principles of ethical conduct of research with human subjects
? Understanding and experience of clinical research
? Knowledge of applicable federal regulations (OHRP, NIH, FDA, and other government agencies) related to human research subjects protection
? Excellent written and oral communication skills
? Excellent analytical, time management and multi-tasking skills
? Ability to edit and write clear, precise and grammatically correct minutes
? Ability to work independently
? Ability to communicate and work with diverse individuals in a professional setting
Special Instructions to Applicants: Applications are accepted electronically ONLY at REQUIRED APPLICATION MATERIALS: 1). A letter of application which specifically addresses the job requirements and outlines qualifications. 2) A current resume/CV. 3) List of 5 professional references and contact information. Questions should be directed to
Application Materials Required:Cover Letter, Resume/CV, List of References
Application Materials Instructions:Applications will be accepted until the position is filled, but full consideration will be given to complete applications received by October 28, 2016. Those who do not apply by October 28, 2016 may or may not be considered. 56e82b48c8194e0aa0eedfa5c6d10df7

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