COMIRB Assistant Director - University of Colorado
Aurora, CO
About the Job
COMIRB Assistant Director - 33731 University Staff
Description
University of Colorado Anschutz Medical Campus
Department: Office of Regulatory Compliance - Colorado Multiple Institutional Review Board (COMIRB)
Job Title: COMIRB Assistant Director
Position #680504 – Requisition #33731
Job Summary:
Key Responsibilities:
+ Serve as an expert resource to the institution, researchers and affiliates regarding federal regulations, state laws, local policies and guidance regarding the protection of participants in human research.
+ Lead meetings between COMIRB and research faculty and teams. Nurture a collaborative culture.
+ Collaborate with all affiliated institutions and institutional officials. and at the CU system level to enhance the research participant protection systems.
+ Lead or participate in education of research staff and investigators including those in the community, in the protection of human research participants, and in compliance with federal and local regulations.
+ Ensure accurate, timely and complete documentation of IRB activities, ensuring human research protocols are in compliance with federal regulations and institutional policies and procedures.
+ Serve as an expert resource for COMIRB staff, IRB members and chairs, regarding federal regulations, state laws, local policies and guidance regarding the protection of participants in human research.
+ Mentor COMIRB staff for reviewing COMIRB applications and meeting with researchers and research staff.
+ Lead or participate in ongoing education of IRB staff, IRB members and chairs.
+ Develop, implement and manage projects to improve consistency and efficiency of internal business processes in COMIRB.
+ Oversee the compliance of emergency use requests and device compassionate use requests.
+ Assist the COMIRB Director to identify possible process improvement opportunities.
+ Assist the COMIRB Director and/or the Associate Vice Chancellor for Regulatory Compliance with additional special projects, as needs arise.
+ Coordinate and/or conduct investigations of non-compliance and complaints in Human Subject Research and make recommendations to the Associate Vice Chancellor for Regulatory Compliance as to appropriate corrective actions.
+ Facilitate the reporting of non-compliance to appropriate federal agencies. utilizing regulatory guidance and collaborate with federal agencies to achieve institutional compliance or appropriate resolution of non-compliance.
+ Back-up support for IRB reliance team
Work Location:
Hybrid
Why Join Us:
Diversity and Equity:
Qualifications:
Minimum Qualifications:
+ A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
+ The position requires at least 4 years of extensive, diverse and progressively responsible experience, including direct responsibility for managing research studies, experience in an academic setting and experience in a compliance role.
_Applicants must meet minimum qualifications at the time of hire._
Preferred Qualifications:
+ A master's degree or higher
+ Extensive experience in research compliance and FDA/OHRP regulations regarding human subject research.
+ Experience with AAHRPP accreditation process and standards, and VA Handbook 1200.05
+ Five or more years of progressively responsible experience in an academic setting.
+ Experience as an educator both in formal and informal settings
Knowledge, Skills and Abilities:
+ 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 biomedical research environment
+ Strong interpersonal, human relations, and conflict resolution skills
+ Ability to plan, organize and 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 lead or manage a work group, staff members, and committees
+ Process improvement and change management skills
How to Apply:
Screening of Applications Begins:
Anticipated Pay Range:
_or hiring range_
_or hiring range_
ADA Statement:
Background Check Statement:
Vaccination Statement:
Job Category
Primary Location
Schedule
Posting Date
Unposting Date
Copyright 2024 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency (https://www.jobelephant.com/)
This full-time, University Staff (non-classified) position serves as the Assistant Director (AD) for the Colorado Multiple Institutional Review Board (COMIRB). COMIRB serves as the IRB for the University of Colorado Denver | Anschutz Medical Center, and our affiliates: Children's Hospital Colorado, Denver Health and Hospital Authority, UCHealth, and the VA Eastern Colorado Health Care System. 45% - Help lead day-to-day stakeholder support: 45% - Supervise day-to-day activities of the COMIRB Office. 5% - Compliance Officer: Serve as a COMIRB panel Compliance Officer and voting IRB member at IRB meetings and facilitate appropriate evaluation of protocols reviewed. 5% - Support other COMIRB activities: 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.
– this role is eligible for a hybrid schedule of #1 days per week on campus and as needed for in-person meetings.
COMIRB serves to protect human research participants' rights and welfare and to promote ethical research by providing high-quality, timely, and consistent reviews of human research, by providing exceptional customer service, and by providing effective consultation, training and guidance for researchers. COMIRB maintains records that document the decisions and operations of the IRBs in compliance with federal regulations and in maintenance of AAHRPP accreditation. Benefits statement to include in all benefits-eligible positions: The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .
The University of Colorado 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, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to: Christin Williamson, Christin.Williamson@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=Christin.Williamson@cuanschutz.edu)
Immediately and continues until position is filled.
The starting salary range () for this position has been established as $88,896 – $113,075 The above salary range () represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. 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. Total Compensation Calculator: http://www.cu.edu/node/153125 (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=http://www.cu.edu/node/153125)
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@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=hr.adacoordinator@cuanschutz.edu) .
The University of Colorado 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.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .
Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 22182 - ADM AVCRC COMIRB : Full-time : May 28, 2024 : Ongoing Posting Contact Name: Christin Williamson Posting Contact Email: Christin.Williamson@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=Christin.Williamson@cuanschutz.edu) Position Number: 00680504jeid-2e6c57467c6a9c4b89a2ac88f71c4871
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.
Description
University of Colorado Anschutz Medical Campus
Department: Office of Regulatory Compliance - Colorado Multiple Institutional Review Board (COMIRB)
Job Title: COMIRB Assistant Director
Position #680504 – Requisition #33731
Job Summary:
Key Responsibilities:
+ Serve as an expert resource to the institution, researchers and affiliates regarding federal regulations, state laws, local policies and guidance regarding the protection of participants in human research.
+ Lead meetings between COMIRB and research faculty and teams. Nurture a collaborative culture.
+ Collaborate with all affiliated institutions and institutional officials. and at the CU system level to enhance the research participant protection systems.
+ Lead or participate in education of research staff and investigators including those in the community, in the protection of human research participants, and in compliance with federal and local regulations.
+ Ensure accurate, timely and complete documentation of IRB activities, ensuring human research protocols are in compliance with federal regulations and institutional policies and procedures.
+ Serve as an expert resource for COMIRB staff, IRB members and chairs, regarding federal regulations, state laws, local policies and guidance regarding the protection of participants in human research.
+ Mentor COMIRB staff for reviewing COMIRB applications and meeting with researchers and research staff.
+ Lead or participate in ongoing education of IRB staff, IRB members and chairs.
+ Develop, implement and manage projects to improve consistency and efficiency of internal business processes in COMIRB.
+ Oversee the compliance of emergency use requests and device compassionate use requests.
+ Assist the COMIRB Director to identify possible process improvement opportunities.
+ Assist the COMIRB Director and/or the Associate Vice Chancellor for Regulatory Compliance with additional special projects, as needs arise.
+ Coordinate and/or conduct investigations of non-compliance and complaints in Human Subject Research and make recommendations to the Associate Vice Chancellor for Regulatory Compliance as to appropriate corrective actions.
+ Facilitate the reporting of non-compliance to appropriate federal agencies. utilizing regulatory guidance and collaborate with federal agencies to achieve institutional compliance or appropriate resolution of non-compliance.
+ Back-up support for IRB reliance team
Work Location:
Hybrid
Why Join Us:
Diversity and Equity:
Qualifications:
Minimum Qualifications:
+ A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
+ The position requires at least 4 years of extensive, diverse and progressively responsible experience, including direct responsibility for managing research studies, experience in an academic setting and experience in a compliance role.
_Applicants must meet minimum qualifications at the time of hire._
Preferred Qualifications:
+ A master's degree or higher
+ Extensive experience in research compliance and FDA/OHRP regulations regarding human subject research.
+ Experience with AAHRPP accreditation process and standards, and VA Handbook 1200.05
+ Five or more years of progressively responsible experience in an academic setting.
+ Experience as an educator both in formal and informal settings
Knowledge, Skills and Abilities:
+ 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 biomedical research environment
+ Strong interpersonal, human relations, and conflict resolution skills
+ Ability to plan, organize and 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 lead or manage a work group, staff members, and committees
+ Process improvement and change management skills
How to Apply:
Screening of Applications Begins:
Anticipated Pay Range:
_or hiring range_
_or hiring range_
ADA Statement:
Background Check Statement:
Vaccination Statement:
Job Category
Primary Location
Schedule
Posting Date
Unposting Date
Copyright 2024 Jobelephant.com Inc. All rights reserved.
Posted by the FREE value-added recruitment advertising agency (https://www.jobelephant.com/)
This full-time, University Staff (non-classified) position serves as the Assistant Director (AD) for the Colorado Multiple Institutional Review Board (COMIRB). COMIRB serves as the IRB for the University of Colorado Denver | Anschutz Medical Center, and our affiliates: Children's Hospital Colorado, Denver Health and Hospital Authority, UCHealth, and the VA Eastern Colorado Health Care System. 45% - Help lead day-to-day stakeholder support: 45% - Supervise day-to-day activities of the COMIRB Office. 5% - Compliance Officer: Serve as a COMIRB panel Compliance Officer and voting IRB member at IRB meetings and facilitate appropriate evaluation of protocols reviewed. 5% - Support other COMIRB activities: 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.
– this role is eligible for a hybrid schedule of #1 days per week on campus and as needed for in-person meetings.
COMIRB serves to protect human research participants' rights and welfare and to promote ethical research by providing high-quality, timely, and consistent reviews of human research, by providing exceptional customer service, and by providing effective consultation, training and guidance for researchers. COMIRB maintains records that document the decisions and operations of the IRBs in compliance with federal regulations and in maintenance of AAHRPP accreditation. Benefits statement to include in all benefits-eligible positions: The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off – vacation, sick, and holidays and more. To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=https://www.cu.edu/employee-services/benefits-wellness) .
The University of Colorado 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, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
For full consideration, please submit the following document(s): 1. A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position 2. Curriculum vitae / Resume 3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address Questions should be directed to: Christin Williamson, Christin.Williamson@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=Christin.Williamson@cuanschutz.edu)
Immediately and continues until position is filled.
The starting salary range () for this position has been established as $88,896 – $113,075 The above salary range () represents the University's good faith and reasonable estimate of the range of possible compensation at the time of posting. This position may be eligible for overtime compensation, depending on the level. 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. Total Compensation Calculator: http://www.cu.edu/node/153125 (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=http://www.cu.edu/node/153125)
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@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=hr.adacoordinator@cuanschutz.edu) .
The University of Colorado 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.
CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf) . If you work, visit, or volunteer in healthcare facilities or clinics operated by our affiliated hospital or clinical partners or by CU Anschutz, you will be required to comply with the vaccination and medical surveillance policies of the facilities or clinics where you work, visit, or volunteer, respectively. In addition, if you work in certain research areas or perform certain safety sensitive job duties, you must enroll in the occupational health medical surveillance program (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) .
Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 22182 - ADM AVCRC COMIRB : Full-time : May 28, 2024 : Ongoing Posting Contact Name: Christin Williamson Posting Contact Email: Christin.Williamson@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=5288268&targetURL=Christin.Williamson@cuanschutz.edu) Position Number: 00680504jeid-2e6c57467c6a9c4b89a2ac88f71c4871
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.
Source : University of Colorado