Job Details

University of Colorado Anschutz Medical Campus

IRB Reliance Coordinator
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Position Number: 5851155
Location: Aurora, CO
Position Type: Health - Public and Environmental Health

IRB Reliance Coordinator

IRB Reliance Coordinator - 35642 University Staff Description

University of Colorado Anschutz Medical Campus

Department: Regulatory Compliance Office - COMIRB

Job Title: IRB Reliance Coordinator

Position #645519: - Requisition #: 35642

Job Summary:

This position serves as the Institutional Review Board (IRB) Reliance Coordinator within the Office of the Colorado Multiple IRB (COMIRB). The IRB Reliance Coordinator is responsible for managing all protocol documents and information related to human subject research protocols submitted to external IRBs. Those IRBs may be private or public, such as WCG, Advarra, the NCI Central IRB, and IRBs at other academic sites. The IRB Reliance Coordinator will manage all aspects of the review documentation including confirming completion of all training requirements, confirming that the University's Conflict of Interest reporting requirements have been met, and other ancillary reviews as required by protocol type. The IRB Reliance Coordinator for managing IRB reliance documentation when COMIRB is serving as a reviewing IRB for unaffiliated sites. The IRB Reliance Coordinator is also responsible for maintaining records that document the decisions and operations of these processes. This position will have to be knowledgeable working with a variety of business systems used for IRB reliances, including but not limited to REDCap, InfoEd, SMART IRB and IREx.

This is a full-time position with minimum work hours of 8am-5pm each day, 40 hours per week. The position is not eligible for overtime.

Key Responsibilities:

The IRB Reliance Coordinator will be responsible for training and assuring that work processes and workflow are understood and adhered to as well as:

Examples of Work Performed include, but are not limited to:

Facilitates issuance of IRB reliances for external IRBs and external sites relying on COMIRB, in accordance with applicable policies, procedures and disclosures.
Serves as a liaison and information resource to University of Colorado Denver (UCD) faculty and staff by advising them on the process for using an external IRB.
Performs initial protocol pre-review process in a timely manner and coordinates with other regulatory and institutional oversight processes as needed.
Verifies that HIPAA language used in protocol submission conforms to standards established by the institution when required.
Provides support and serves as a resource to research teams requiring IRB reliances.
Implements procedures and practices designed to promote compliance with other regulatory processes such as COI policies and with COI management plans as well as HIPAA authorization, and other regulatory and locally required reviews.
Maintains accurate, timely and complete records that are in compliance with federal, state and local regulations and requirements.
Performs random audits of the InfoEd database to ensure accuracy of records and data entry as they relate to the use of IRB reliances.

Work Location:

Hybrid - this role is eligible for a hybrid schedule of 1 day per week on campus and as needed for in-person meetings.

Why Join Us:

The Colorado Multiple Institutional Review Board (COMIRB) includes five institutional review boards (IRBs) for review of human subjects research for the University of Colorado Denver | Anschutz Medical Campus and its affiliates: Children's Hospital Colorado, Denver Health and Hospital Authority, University of Colorado Health, and the VA Eastern Colorado Health Care System.

Actions by COMIRB will be guided by the principles of respect for persons, beneficence, and justice set forth in the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (often referred to as the Belmont Report). Learn more about our continuous quality improvement.

Why work for the University?

We have AMAZING benefits and offer exceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:

Medical: Multiple plan options
Dental: Multiple plan options
Additional Insurance: Disability, Life, Vision
Retirement 401(a) Plan: Employer contributes 10% of your gross pay
Paid Time Off: Accruals over the year
Vacation Days: 22/year (maximum accrual 352 hours)
Sick Days: 15/year (unlimited maximum accrual)
Holiday Days: 10/year
Tuition Benefit: Employees have access to this benefit on all CU campuses
ECO Pass: Reduced rate RTD Bus and light rail service

There are many additional perks & programs with the CU Advantage.

Diversity and Equity:

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, ethnically minoritized individuals, persons with disabilities, persons within the LGBTQ+ community and all veterans. In addition, the Anschutz Campus has also been recognized as an Age-Friendly University. The University of Colorado is committed to diversity and equality in education and employment.

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
1 year of professional level experience dealing appropriately with highly confidential and sensitive personnel issues.
- A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.

Applicants must meet minimum qualifications at the time of hire.

Preferred Qualifications:

Experience in an IRB office or similar regulatory support role
Experience in working in a training capacity

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.
Ability to communicate effectively both orally and in writing.
Strong customer service
Strong attention to detail
Ability to plan, organize and meet deadlines, work under pressure, and organize multiple projects or tasks
Comprehensive personal computing skills and ability to work with complex relational databases
Ability to independently work and self-regulate multiple priorities/tasks
Excellent interpersonal skills are required to establish and maintain collaborations and working relationships with committees, faculty, administration, staff and students.

How to Apply:

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 (only use if a cover letter is necessary)

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

Screening of Applications Begins:

Applications will be accepted until finalists are identified, but preference will be given to complete applications received by December 28, 2024. Those who do not apply by this date may or may not be considered.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as (55,496).

The above salary range (or hiring 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

ADA Statement:

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.

Background Check Statement:

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.

Vaccination Statement:

CU Anschutz strongly encourages vaccination against the COVID-19 virus and other vaccine preventable diseases. 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.
Application Materials Required: Cover Letter, Resume/CV, List of References Job Category
: Research Services Primary Location
: Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 22182 - ADM AVCRC COMIRB Schedule
: Full-time Posting Date
: Dec 5, 2024 Unposting Date
: Ongoing Posting Contact Name: Christin Williamson Posting Contact Email: Christin.Williamson@cuanschutz.edu Position Number: 00645519

To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=35642&lang=en