Regulatory Affairs Coordinator (RAC) (Entry - Senior Level)
Company: University of Colorado Anschutz Medical Campus
Location: Aurora
Posted on: May 2, 2025
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Job Description:
University Staff Description University of Colorado Anschutz
Medical Campus
School of Medicine - Department of Medicine - Division of
Hematology
Job Title: Regulatory Affairs Coordinator (RAC) (Entry - Senior
Level)
Position: #00833812 - Requisition: #36725
Job Summary:
The University of Colorado Division of Hematology, Clinical Trials
Unit is seeking a Regulatory Affairs Coordinator. This position is
responsible for providing regulatory support for clinical trials
and investigator-initiated studies for the Division of
Hematology.
The Regulatory Affairs Coordinator (RAC) will work closely with the
HCTU Leadership Team, Principal Investigators, Industry Sponsor/CRO
Representatives, IRBs, and other departments on campus to provide
support for the Division's clinical trial portfolio. This position
will provide support for studies that may involve
industry-sponsored Phase I, II, III, and IV clinical trials and
investigator-initiated studies. The RAC will ensure the accurate
progress of clinical research from the planning and approval stages
through study completion and post-study closure.
Key Responsibilities:
Serves as regulatory contact person for ongoing clinical research
studies and meets with representatives from sponsoring
pharmaceutical firms or in-house staff for initial orientation to
studies and for review of regulatory records.
Submits complete and accurate clinical research applications to all
required regulatory bodies for the conduct of clinical research at
the University of Colorado. This may include, but is not limited
to, the following:
Colorado Multiple Institutional Review Board (COMIRB)
Protocol Review and Monitoring System (PRMS)
Hospital Research Support Services (UCH-RSS)
University of Colorado Hospital Biosafety Committee (IBC)
University of Colorado Hospital Clinical Trials Research Center
(CTRC)
Writes clear and accurate subject informed consent documents and
HIPAA (Health Insurance Portability and Accountability Act)
Authorizations.
Completes and submits continuing reviews, amendments, and safety
updates as needed.
Participates in Data Safety Monitoring Committee (DSMC) internal
audits.
Updates database with regulatory submission and approval dates.
Work Location:
Hybrid - this role is eligible for a hybrid schedule of two (2)
days per week on campus and as needed for in-person meetings.
Why Join Us:
Investigators in the Division of Hematology's Blood Cancer Program
are actively engaged in multiple research activities aimed at
improving outcomes for patients with blood cancers and related
disorders. These studies are wide-ranging and involve extensive
collaboration between laboratory scientists and physicians. Our
work is funded by the National Cancer Institute (NCI), the American
Cancer Society (ACS), the Leukemia and Lymphoma Society (LLS), and
numerous other foundations and industry sources.
A key strength of our research group is its highly collaborative
and cross-disciplinary nature, which provides an ideal environment
in which to develop new therapies. The Hematology Clinical Trials
Unit (HCTU) plays an integral role in conducting the clinical
research components of the division and has made bringing
bench-to-bedside research a huge divisional success. The HCTU is
comprised of over 30 employees, and their dedication and investment
each day is seen and felt by patients who have and will participate
in a clinical trial.
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 .
Qualifications:
Minimum Qualifications:
Entry Level:
Bachelor's degree in any field.
Intermediate Level:
Bachelor's degree in any field.
One (1) year of clinical regulatory compliance or related
experience.
Senior Level:
Bachelor's degree in any field.
Two (2) years of clinical regulatory compliance or related
experience.
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:
Bachelor's degree in science or health related field.
One (1) to three (3) years of clinical research or related
experience.
Knowledge, Skills, and Abilities:
Knowledge and understanding of federal regulations and Good
Clinical Practice (GCP).
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.
Knowledge of basic human anatomy, physiology, and medical
terminology.
Ability to interpret and master complex research protocol
information.
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.
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: Daniel Page,
Screening of Applications Begins:
Immediately and continues until position is filled. For best
consideration, apply by May 15th, 2025.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has
been established as
Entry Level: $50,996 - $64,867
Intermediate Level: $55,495 - $70,590
Senior Level: $59,995 - $76,314
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:
Equal Employment Opportunity Statement:
The University of Colorado (CU) is an Equal Opportunity Employer
and complies with all applicable federal, state, and local laws
governing non-discrimination in employment. We are committed to
creating a workplace where all individuals are treated with respect
and dignity, and we encourage individuals from all backgrounds to
apply.
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
.
Qualifications
Application Materials Required: Cover Letter, Resume/CV, List of
References Job Category: Research Services Primary Location: Hybrid
Department: U0001 -- Anschutz Med Campus or Denver - 20164 -
SOM-MED-BoneMarrow Transplant Schedule: Full-time Posting Date: Apr
28, 2025 Unposting Date: May 16, 2025, 5:59:00 AM Posting Contact
Name: Daniel Page Posting Contact Email: daniel.page@cuanschutz.edu
Position Number: 00833812
Keywords: University of Colorado Anschutz Medical Campus, Aurora , Regulatory Affairs Coordinator (RAC) (Entry - Senior Level), Other , Aurora, Colorado
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