Regulatory Affairs Coordinator (Open Rank: Intermediate Senior)
Description
University of Colorado Anschutz Medical Campus
Department: Neurology
Job Title: Regulatory Affairs Coordinator (Open Rank: Intermediate - Senior)
Position #: 00 841737 - Requisition #:40161
Job Summary:
Key Responsibilities:
Facilitate completion of initial essential regulatory documents (FDA 1572, Financial Disclosure forms, PI signature pages, etc)
Create/organize regulatory binder and/or electronic files for new studies and maintain regulatory binder and/or electronic files throughout the course of the study, file/update all required documents and ongoing training/certifications appropriately
Oversee training logs and delegation of duties logs, working with study coordinator to ensure completion prior to enrollment and ongoing accurate maintenance throughout the study
Maintain documentation of all relevant training
Prepare for and manage regulatory portion of industry study monitor visits, addressing all regulatory action items
Create informed consent documents for new studies and update informed consent documents as needed throughout the study
Facilitate process for investigator receipt and evaluation of external IND safety reports
Other duties as assigned
Work Location:
Hybrid
Why Join Us:
The University of Colorado Anschutz Medical Campus is the largest academic health center in the Rocky Mountain region at the forefront of transformative education, science, medicine, and healthcare. The campus includes the University of Colorado health professional schools, multiple centers, and institutes and two nationally ranked hospitals, UCHealth University of Colorado Hospital and Children's Hospital Colorado, which treat nearly 2 million patients each year. All interconnected, these organizations collaboratively improve the quality of patient care they deliver, research they conduct and health professionals they train.
Why work for the University?
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
Why work for the University?
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
Equal Employment Opportunity Statement:
Qualifications:
Minimum Qualifications:
Entry Level:
A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution
Intermediate Level:
A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution
1 year professional experience in a clinical research setting with regulatory responsibilities
Senior Level:
A bachelor's degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, or a directly related field from an accredited institution
2 years professional experience in a clinical research setting with regulatory responsibilities
Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year for year basis.
Condition of Employment:
Willing and able to work occasional extended hours to meet work location needs
Preferred Qualifications
Experience working with Principal Investigators (PIs)
1 year Project Management experience
3 years of regulatory experience
IRB experience (COMIRB or central IRB, such as WCG or Advarra)
Protocol writing
Experience with University of Colorado/UCHealth systems (Colorado Multiple Institutional Review Board, UCHealth Research Administration, Oncore, InfoED, and Neurology NeuroCRAFT, Veeva).
Experience with clinical trial management systems and web-based protocol submission systems.
Experience with administrative duties, such as drafting documents and correspondence, preparing reports, proofreading, operating general office equipment (i.e. copy machine, fax machine, scanner)
How to Apply:
A letter of interest describing relevant job experiences as they relate to listed job qualifications and interest in the position
Curriculum vitae / Resume
Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address
Screening of Applications Begins:
Anticipated Pay Range:
Entry: $52,860-$67,239
Intermediate: $57,525-$73,171
Senior: $62,189-$79,104
ADA Statement:
Background Check Statement:
Vaccination Statement:
Job Category
Primary Location
Schedule
Posting Date
Unposting Date
To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=40161&lang=en (https://apptrkr.com/7217904)
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Regulatory Affairs Coordinator (Open Rank: Intermediate - Senior) - 40161 University Staff
The Department of Neurology has an immediate opening for a full-time Regulatory Affairs Coordinator. The position will independently maintain and manage all IRB and regulatory processes for multi-site sponsored research studies relying on a central IRB. Primary duties will include, but not be limited to: submissions to the Institutional Review Board (IRB) of record including amendments, unanticipated problems, continuing reviews, and study closures; maintenance of the investigator site file/regulatory binder and all essential documents including documentation of appropriate training and delegation for all personnel; submissions to internal University and Hospital research portals; acting as primary regulatory contact person for sponsors/Contract Research Organizations (CROs)/coordinating centers; and training UCD Neurology Clinic Research personnel to promote good clinical practice (GCP) and compliance with all applicable regulations. The Regulatory Affairs Coordinator will work closely with the Senior Clinical Research Regulatory Manager, subspecialty program managers, and clinical research coordinators.
this role is eligible for a hybrid schedule of 3 days per week on campus and as needed for in-person meetings.
We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:There are many additional perks & programs with the https://apptrkr.com/get\redirect.php?id=7217904&targetURL=We have AMAZING benefits and offerexceptional amounts of holiday, vacation and sick leave! The University of Colorado offers an excellent benefits package including:There are many additional perks & programs with the CU Advantage (https://apptrkr.com/get\redirect.php?id=7217904&targetURL=https://advantage.cu.edu/) .
CU is an Equal Opportunity Employer and complies with all applicable federal, state, and local laws governing nondiscrimination 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, including protected veterans and individuals with disabilities.
:Applicants must meet minimum qualifications at the time of hire.
For full consideration, please submit the following document(s):Questions should be directed to: Neurology-hr@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=7217904&targetURL=Neurology-hr@cuanschutz.edu)
Applications will be accepted until finalists are identified, but preference will be given to complete applications received by August 1, 2025. Those who do not apply by this date may or may not be considered.
The starting salary range (or hiring range) for this position has been established asThe 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 (https://apptrkr.com/get_redirect.php?id=7217904&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=7217904&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=7217904&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=7217904&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Hybrid Department: U0001 -- Anschutz Med Campus or Denver - 20244 - SOM-NEUR GENERAL OPERATIONS : Full-time : Jun 5, 2026 : Ongoing Posting Contact Name: Neurology-hr Posting Contact Email: Neurology-hr@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=7217904&targetURL=Neurology-hr@cuanschutz.edu) Position Number: 00841737jeid-9bb14720c0a99b4fb907c082b47b06f6
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.
