Radiation Safety Committee Coordinator
Company: University of Colorado Anschutz Medical Campus
Location: Aurora
Posted on: November 16, 2024
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Job Description:
University Staff Description University of Colorado Anschutz
Medical Campus
Department: Office of Regulatory Compliance - Office of Research
Committee Support
Job Title: Radiation Safety Committee Coordinator
Position #653169: - Requisition #: 35076
Job Summary:
This position serves to organize and manage administrative support
for the following federal- state- or institutionally- mandated
Radiation Safety Committees under the auspices of the Office of
Research Committee Support (ORCS), for research regulatory
compliance:
Radioactive Drug Research Committee (RDRC) - Federally mandated
under the FDA, the Committee reviews and approves all research
involving radioactive drug use in human subjects, concurrent with
the Colorado Multiple Institutional Review Board (COMIRB). The RDRC
research review is performed in accordance with mandated federal
regulations.
Committee on Ionizing Radiation (CIR) - State mandated Committee.
The CIR provides oversight of the entire Radiation Safety Program,
reviews and approves all research involving radioactive materials
in research on behalf of the University.
Committee on Ionizing Radiation for Human Use (HuCIR) - Committee
reviews and approves all research involving use of radioactive
materials in humans.
Key Responsibilities:
Committee Meeting Coordination
Responsible for planning, coordinating, and staffing committee
meetings. Works with the Radiation Safety Office, Radiation Safety
Committees Chair(s) and committee members to develop meeting
schedules, arrange meeting rooms and necessary audiovisual or
computer support for meetings; prepares the meeting agenda and
oversees protocol packet preparation and distribution to Committee
members and assures a quorum is available to convene the meeting
and conduct committee business.
Serves as the recorder for minutes (in addition to using electronic
recording equipment) at Committee meetings to ensure that the
minutes accurately reflect the meeting content. Must be able to
understand and transcribe upper level technical, medical and legal
language, and research concepts.
Transcribes handwritten notes, email reviews/comments from
Committee members and the electronic recordings to prepare draft
meeting minutes for review by the committee. Corrects or amends
draft documents to ensure that the minutes accurately reflect the
meeting content and ensures that minutes comply with federal
standards.
Responsible for entering results of deliberations, and voting on
applications, at convened meetings into the appropriate
databases.
Regulatory Support
Responsible for ensuring that the Committee's policies and
procedures are consistently applied to all applications (projects,
protocols) submitted for review to the Office of Research Committee
Support and the Radiation Safety Committees.
Work closely with the Radiation Safety Division of l Environmental
Health & Safety (EHS) and Office of Regulatory Compliance
staff.
Work closely with IACUC and COMIRB offices to correctly coordinate
review and approval of research protocols involving radioactive
material used in animal or human research.
Serve as point of contact for questions from researchers conducting
research involving radioactive materials pertaining to appropriate
forms and processes for approval.
Works with the Radiation Safety Division of EHS to conduct
pre-review of all applications submitted and prioritizes protocols
for review at meetings and creates the agenda with the pertinent
information.
In conjunction with the Radiation Safety Division of EHS, the
Coordinator may perform internal audits of designated research
facilities to ensure the proper maintenance and accuracy of
protocol files and data entry according to federal regulatory
requirements and Committee administration SOPs or guidelines to
ensure the timeliness, correctness and compliance of reviews
conducted by the respective committees, and verifying compliance
with CDPHE license conditions and 21 CFR 361.1 rules. The
expectation is that there would be approximately 2 to 4 days per
month of direct, in person coordination with the Radiation Safety
Division.
Committee Administrative support
The individual manages all administrative aspects of the receipt of
incoming applications (protocols, projects) and related documents
(amendments, addenda, supporting documents) received by the
Radiation Safety Program in electronic format.
Responsible for checking the Radiation Safety Program email
accounts daily for incoming application forms and supporting
documentation and responses to requests for information from
Principal Investigators.
Saves all applications and supporting documents as electronic files
for internal pre-review by the Radiation Safety Office.
Enters all pertinent data upon receipt of applications, amendments
and any other supporting documents in the Radiation Safety Program
database, spreadsheets, and the EHS-Assistant database, as
necessary.
Important resource to faculty and research staff who have committee
process-related questions to be addressed. They work with the
Radiation Safety Committees on the drafting, development and
publication of committee policies and administrative procedures as
well as assisting in the development of the committee website.
Perform other job duties as assigned.
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 CU Denver - Anschutz Medical Campus Office of Regulatory
Compliance through the auspices of the Office of Research Committee
Support (ORCS) exercises regulatory compliance and compliance
oversight for research conducted at CU Denver campuses and off-site
laboratories.
This responsibility includes management of research protocol review
for the Committees governing the use of animals, biological,
chemical or radioactive materials (in humans or animals). In this
capacity, ORCS provides the administrative support for the
Radioactive Drug Research Committee (RDRC), the Committee on
Ionizing Radiation (CIR), and the Human Use Committee on Ionizing
Radiation (HuCIR), to assure regulatory compliance and safety
oversight for research activities and materials in accordance with
applicable Federal, State and local regulations which govern the
use of radioactive materials in research.
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 .
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 and 1 year of
professional level experience managing research studies.
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 working with AWA/PHS (OLAW) regulations regarding animal
subject research.
Experience working with FDA/OHRP regulations regarding human
subject research.
Experience working with CDPHE regulations pertaining to the safe
use of radioactive materials and radiation producing equipment
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 FDA Guidelines for research involving
radioactive materials.
Knowledge of higher educational and/or the research
environment.
Ability to communicate effectively both in writing and orally.
Strong interpersonal and human relations skills.
Strong analytical and problem solving skills.
Ability to plan, organize and meet deadlines, work under pressure,
and organize multiple projects or tasks.
Comprehensive personal computing skills and ability to manage
information in complex relational databases.
Ability to effectively support the Committee, Chair(s),
investigators, and contribute to working groups, staff meetings,
and other committees as assigned
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: Natalie Serkova,
Natalie.Serkova@cuanschutz.edu
Screening of Applications Begins:
Immediately and continues until position is filled. For best
consideration, apply by October 17, 2024.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has
been established as $55,496 - $70,590.
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:
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 .
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 . 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
.
Application Materials Required: Cover Letter, Resume/CV, List of
References Job Category: Research Services Primary Location: Hybrid
Department: U0001 -- Anschutz Med Campus or Denver - 21093 - ADM
AVCRC - Administration Schedule: Full-time Posting Date: Oct 3,
2024 Unposting Date: Ongoing Posting Contact Name: Natalie Serkova
Posting Contact Email: Natalie.Serkova@cuanschutz.edu Position
Number: 00653169
Keywords: University of Colorado Anschutz Medical Campus, Southglenn , Radiation Safety Committee Coordinator, Accounting, Auditing , Aurora, Colorado
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