Research Services Professional (Regulatory and Pre-Award) - Open Rank
Description
University of Colorado Anschutz Medical Campus
Department: Radiology
Job Title: (Regulatory and Pre-Award) - Open Rank
Position #: - Requisition #:37500
Job Summary:
Research Services Professional Pre-Award activities regulatory support
Principal Investigators (PIs) proposal development regulatory documentation compliance with institutional, federal, and sponsor guidelines
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.
Work Location:
Onsite
Why Join Us:
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
Qualifications:
Minimum Qualifications:
Entry Level
Bachelor's 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
Bachelor's 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, grants management ( pre-or post-award) or related experience. Experience with electronic data capture systems (e.g. EMR or EHR and data management systems).
Senior Level
Bachelor's 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, grants management ( pre-or post-award) or related experience. Experience with electronic data capture systems (e.g. EMR or EHR and data management systems)
A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's 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:
Screening of Applications Begins:
Anticipated Pay Range:
Senior Professional: $56,553 - $71,936
Intermediate Professional: $52,312 - $66,541
Entry Professional: $48,070 - $61,145
Equal Employment Opportunity Statement:
ADA Statement:
Background Check Statement:
Vaccination Statement:
Job Category
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Posting Date
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To apply, visit https://cu.taleo.net/careersection/2/jobdetail.ftl?job=37500&lang=en (https://apptrkr.com/6456518)
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Research Services Professional (Regulatory and Pre-Award) - Open Rank - 37500 University Staff
The Department of Radiology is seeking a dedicated and detail-oriented to join our team. This full-time position will be responsible for managing and providing for an assigned portfolio of grants, contracts, and subcontracts.The successful candidate will work closely with and research staff to coordinate , assist with , and ensure . 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.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
this role is expected to work onsite and is located in Aurora, CO.
Use your college/unit or department as a selling point. Think about the "what's 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.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=6456518&targetURL=https://advantage.cu.edu/) .
Applicants must meet minimum qualifications at the time of hire.
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 position2. Curriculum vitae / Resume3. Three to five professional references, including name, address, phone number (mobile number if appropriate), and email address
Immediately and continues until position is filled. For best consideration, apply by August 25, 2025.
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 (https://apptrkr.com/get_redirect.php?id=6456518&targetURL=http://www.cu.edu/node/153125)
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.
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=6456518&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=6456518&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=6456518&targetURL=https://research.cuanschutz.edu/ehs/home/divisions/occupational-health/oh-enrollment) . Application Materials Required: Cover Letter, Resume/CV, List of References : Research Services : Aurora Department: U0001 -- Anschutz Med Campus or Denver - 20295 - SOM-RAD GENERAL OPERATIONS : Full-time : Aug 8, 2025 : Ongoing Posting Contact Name: Cindy Mansfield Posting Contact Email: cindy.mansfield@cuanschutz.edu (https://apptrkr.com/get_redirect.php?id=6456518&targetURL=cindy.mansfield@cuanschutz.edu) Position Number: 00838530jeid-1e0381a1965aad4a8fe2d1b3fb320fb7
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.
