Research Services Professional (Regulatory and Pre-Award) - Open Rank

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 "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.

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 CU Advantage.

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)

Applicants must meet minimum qualifications at the time of hire.

• 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:

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: $56,553 - $71,936

• Intermediate Professional: $52,312 - $66,541

• Entry Professional: $48,070 - $61,145

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:

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 hr.adacoordinator@cuanschutz.edu

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 vaccine 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, 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.