IRB Panel Coordinator

Applications are accepted electronically ONLY at www.cu.edu/cu-careers
University of Colorado Denver/Anschutz Medical Center
Colorado Multiple Institutional Review Board, Office of Regulatory Compliance
Job Title: IRB Panel Coordinator
Position Number: 652139 - Requisition (05918)
Job Summary:
The IRB Panel Coordinator will oversee the work flow to ensure that the Colorado Multiple Institutional Review Board (COMIRB) conducts reviews of submitted human subject research applications in accordance with federal requirements, COMIRB policies and procedures and accreditation standards. Specifically, the IRB Panel Coordinator will work with personnel in all areas of the submission and review process to ensure appropriate preview of all protocols applications and consent forms; plan COMIRB panel meetings, synthesize meeting reports and ensure that meeting reports are completed in accordance with federal requirements and COMIRB policies and procedures; database entry and generating written feedback letters to investigators; and provide support to faculty and research staff on research submissions, training requirements, and up-dated processing procedures.
Professional Field
COMIRB is the IRB that serves a consortium of academic and health care facilities in Colorado consisting of: University of Colorado Downtown Denver Campus; University of Colorado Denver Anschutz Medical Campus; Denver Health Medical Center; Denver Veterans Affairs Medical Center; Children's Hospital Colorado; and the University of Colorado Hospital.
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.
Examples of work performed include but are not limited to:
1. Serve as a liaison and information resource to University of Colorado Denver (UCD) faculty and staff by advising them on all federal requirements and university policies for approval of research with humans.
2. Conduct an internal pre-review of all protocols submitted to the panel. Prepare research submissions for expert review by interacting with investigators to ensure appropriate and complete protocol submission.
3. Assist in problem solving by acting as the key COMIRB administrative liaison between the COMIRB panel and the investigator. Generate post-review feedback to investigators.
4. Responsible for coordinating a committee to review research protocols for compliance with human subject research protection regulations.
5. Plan, coordinate, and staff committee meetings.
6. Work with committee members to develop meeting schedule, arrange meeting rooms, prioritize protocols to go to meetings, match and assign protocols to COMIRB reviewers with appropriate expertise, prepare agenda of protocols to be reviewed, oversee protocol packet preparation and distribution to reviewers, provides all necessary materials for meetings, staffs the meetings, provides expert advice during panel meetings on federal and COMIRB regulations.
7. Attend and observe COMIRB meetings in order to synthesize meeting reports that accurately reflect the meeting content.
8. 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.
9. Ensure that the minutes comply with federal and accreditation standards and are processed in a timely manner.
10. Perform internal audits to ensure the proper maintenance and accuracy of protocol files and data entry according to federal regulatory requirements and COMIRB SOPs/guidelines to ensure the timeliness, correctness and compliance of reviews conducted by the panel.
11. Frequently file documents, lift and carry files, which weigh up to 25 pounds.
Supervision Exercised:
The IRB Panel Coordinator will not directly supervise any staff but will need to work closely with other COMIRB staff to ensure that there is consistency across panels in an attitude of teamwork.
This is a full-time position with minimum work hours of 8-5 Monday through Friday.
Salary and Benefits:
The hiring salary for this position is $38,000 - $40,000 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 athttps://www.cu.edu/employee-services.
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.
Qualifications:
Minimum Requirements:
Bachelor's degree in business administration, public administration, healthcare administration, education or other closely related field.
Substitution:
+ Professional experience working with Institutional Review Boards or in research studies will substitute for a bachelor's degree on a year-for-year basis.
+ A master's degree in science or a related field will substitute for the bachelor's degree.
Conditions of Employment
1. Must be willing and able to sit and stand for long periods of time
2. Must be willing and able to lift and carry up to 25 pounds. Required
Preferred Qualifications:
1. Experience working with Institutional Review Boards or OHRP/FDA regulations regarding human subject research
2. Certified IRB Manager (CIM) or Certified IRB Professional (CIP) qualifications 3. Experience with research and/or health care
4. Experience in an academic setting
Competencies: Knowledge, Skills & Abilities:
1. Working knowledge of Office for Human Research Protections (OHRP) and Food and Drug Administration (FDA) regulations for human subject research
2. Knowledge of higher educational and/or research environment
3. Ability to communicate effectively both orally and in writing
4. Strong interpersonal and human relations skills
5. Strong analytical and problem solving skills
6. Ability to plan, meet deadlines, work under pressure, and organize multiple projects or tasks
7. Comprehensive computer skills and ability to work with complex databases
8. Ability to effectively support the panel team and contribute to working groups, staff meetings, and other committees as assigned
9. Flexibility and adaptability.
Special Instructions to Applicants: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. 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. Questions should be directed to Prapti Bisht at Prapti.Bisht@ucdenver.edu.
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 August 1, 2016. Those who do not apply by August 1, 2016 may or may not be considered. 78b99413bc6b47f29b3d2be4733fbf32

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