Research Services Professional (Regulatory and Pre-Award) - Open Rank
Research Services Professional (Regulatory and Pre-Award) - Open Rank
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Job Description
University of Colorado Anschutz Medical Campus
Department: Radiology
Job Title: Research Services Professional (Regulatory and Pre-Award) - Open Rank
Position #: Requisition #:37500
Job Summary:
The Department of Radiology is seeking a dedicated and detail-oriented Research Services Professional to join our team. This full-time position will be responsible for managing Pre-Award activities and providing regulatory support for an assigned portfolio of grants contracts and subcontracts.
The successful candidate will work closely with Principal Investigators (PIs) and research staff to coordinate proposal development assist with regulatory documentation and ensure compliance with institutional federal and sponsor guidelines. This role is critical in supporting the administrative and operational aspects of research to facilitate high-quality and compliant submissions. This position will report to the Research Services Program Director with additional oversight from the Clinical Trials Manager.
Examples of Duties Performed
Regulatory- 40%
Submit clinical trial protocols with applicable essential documents to our local IRB (COMIRB) WCG CIRB Advarra etc.
Ensure adherence to local federal and institutional research regulatory standards and guidelines.
Manage all regulatory aspects of study start-up and ongoing maintenance ensuring studies open on time and remain compliant.
Maintain thorough and organized records for all studies to ensure compliance with FDA regulations study protocols departmental procedures clinical standard operating procedures (SOPs) and sponsor requirements
Pre-Award- 50%
Support Principal Investigators (PIs) in preparing all required documentation for grant and sub/contract proposal submissions.
Collaborate with faculty staff and research teams to plan coordinate and support research proposal submissions.
Track and monitor proposal deadlines ensuring timely and compliant submission of all materials.
Provide guidance on pre-award procedures including sponsor-specific requirements institutional policies and submission processes.
Assist with compiling and collecting required documents for grant proposals ensuring adherence to sponsor and institutional formatting and compliance guidelines.
Coordinate with external collaborators to gather and finalize subaward documentation; manage Just-In-Time submissions.
Facilitate routing and submission through Infoed.
Collaborate with the research team to develop refine and enhance pre-award processes policies and procedures.
Prepare administrative documents and reports; initiate SpeedType # request and other related tasks.
Maintain accurate records of proposals submissions and funding opportunities
Clinical and Other- 10%
Occasionally serve as clinical trial coordinator back-up including assisting with pre-screening and consenting potential clinical trial participants.
Perform informed consent process or ensure it has been properly conducted fully documented and that consent forms are accurately filed in accordance with regulatory requirements.
Route various research-related agreements (e.g. Material Transfer Agreement MTAs Confidential Disclosure Agreements CDAs Non-Disclosure Agreements NDAs license agreements) for institutional review and signature.
Process Standing Purchase Orders (SPOs) for subcontracts and fee-for-service arrangements through CU Marketplace; submit and track corresponding invoices for payment.
This description provides a general summary of the key responsibilities and scope of work for this position. It is not comprehensive and may change over time to meet the evolving needs of the department. The supervisor and/or hiring authority reserve the right to modify add or remove duties as necessary
Work Location:
Onsite this role is expected to work onsite and is located in Aurora CO.
Why Join Us:
Use your college/unit or department as a selling point. Think about the whats in it for me candidate viewpoint. You do not need to include everything just the most appealing parts of working for your college/unit or department. Keep this section short and concise for effectiveness - in general try to limit it to 1-2 paragraphs.
Why work for the University
We haveAMAZINGbenefits and offerexceptional 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.
Qualifications:
Minimum Qualifications:
Entry Level
Bachelors degree in science health related field management business or relevant degree and administrative experience OR combination of education and experience in sponsored programs administration equivalent. Candidates with other equivalent qualifications may be considered.
Intermediate Level
Bachelors degree in science health related field management business or relevant degree and administrative experience OR combination of education and experience in sponsored programs administration equivalent. Candidates with other equivalent qualifications may be considered.
One (1) year of clinical research grantsmanagement ( pre-or post-award) or related experience. Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
Senior Level
Bachelors degree in science health related field management business or relevant degree and administrative experience OR combination of education and experience in sponsored programs administration equivalent. Candidates with other equivalent qualifications may be considered.
Two (2) years of clinical research grantsmanagement ( pre-or post-award) or related experience. Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
Applicants must meet minimum qualifications at the time of hire.
A combination of education and related technical/paraprofessional experience may be substituted for the bachelors degree on a year for year basis.
Preferred Qualifications:
Experience in industry and/or PI initiated sponsored clinical research trials.
Regulatory experience
HIPAA and human subjects certifications
Experience working in the EPIC electronic medical record system
Experience working in the OnCore research management system
Knowledge of Good Clinical Practice (GCP) guidelines and FDA regulations
Ability to work on audits of clinical trials
Experience with databases and data entry procedures
Excellent interpersonal communication organizational skills and ability to problem-solve and multi-task
Knowledge of basic human anatomy physiology and medical terminology
Ability to use MS Excel at an intermediate level
Experience with NIH grants and policies
Experience with financial analysis and/or management
Experience with University of Colorado systems including InfoEd electronic research administration and/or PeopleSoft HCM/Finance
Experience in an academic or research healthcare organization (preferred)
Experience in sponsored administration or higher education programs (preferred)
Experience working in the University of Colorado system or other higher education environment
Experience with University Expense and Procurement System software and applications and grant management systems (m-Fin Concur CU Marketplace eRA Commons InfoEd etc.)
Experience with contracts (e.g. subcontracts/subawards) and sub-recipient invoice monitoring
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
Demonstrated commitment and leadership ability to advance diversity and inclusion
Knowledge of basic human anatomy physiology medical terminology
Ability to interpret and master complex research protocol information
Ability to handle sensitive matters that require discretion and confidentiality
Possesses knowledge base in grants and contracts administration and can apply that knowledge to the task or issue at hand. Interpretation of terms and conditions and ensuring the correct application of terms and conditions of research awards is essential
Excellent organizational skills with the ability to problem-solve multi-task and work independently
Ability to work in a self-directed manner take appropriate initiative and work proactively with minimal direction.
Ability to establish work priorities and follow through to ensure completion of activities
Proficiency in Microsoft Office specifically Word Teams and Outlook with ability to develop professional correspondence documents spreadsheets etc
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
Screening of Applications Begins:
Immediately and continues until position is filled. For best consideration apply by August 25 2025.
Anticipated Pay Range:
The starting salary range (or hiring range) for this position has been established as
Senior Professional: $56553 - $71936
Intermediate Professional: $52312 - $66541
Entry Professional: $48070 $61145
The above salary range (or hiring range) represents the Universitys 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.
Equal Employment Opportunity Statement:
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.
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 othervaccine 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 addition if you work in certain research areas or perform certain safety sensitive job duties you must enroll in theoccupational health medical surveillance program.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
