Pre-Award Specialist

Job Summary:

The Oncology Clinical Research Pre Award Specialist is responsible for developing, negotiating, finalizing and reviewing budgets for clinical trials conducted by faculty members of the University of Colorado Cancer Center at University of Colorado Hospital (UCH). This position requires discretion, analytical skill & personal responsibility to identify, research, collaborate and creativity solve problems in a changing environment while remaining within system, institutional, and state fiscal policies. This position works extensively with individual pharmaceutical companies, CU finance contacts, clinical staff, faculty members, the University of Colorado Hospital, administrative staff throughout the University, as well as representatives from various departments and CU Medicine. There is a lot of training up front as this position must learn a Medicare Coverage Analysis (MCA), oncology clinical trial protocols, processes and procedures of the oncology clinical trial Post Award specialist, the oncology clinical trial finance/billing specialist, clinic staff.

Job trainings and functions include reviewing and analysis of complex oncology clinical trial protocols, drafting a study-specific budget to account for all procedural and labor costs, working with our clinical trial system, OnCore^TM, calendar builders and Project/Research managers to ensure all cost are properly accounted for. This position is also responsible and will be trained for contracts/ grants solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and pre-award management. This position will have budgetary oversight and is responsible for the advancement of oncology clinical trial contracts and amendments sponsored by industry, co-operative groups, federal grants/contracts and investigator initiated clinical trials.

Key Responsibilities:

Specific Examples of Work Performed (All Levels):

• Review clinical trial protocols in order to draft a study-specific budget that accounts for all procedural and labor costs.

• Negotiate budgets with industry sponsors.

• Review and negotiate contractual payment terms

• Work with the Clinical Research Administration Office (CRAO) to review and approve final contracts (budget related sections and exhibits)

• Work with OnCore^TM calendar builders to ensure financial information in OnCore^TM, accurately portrays procedures, rates and prices in the negotiated budgets.

• Review contractual documents to ensure final negotiated terms have been incorporated.

• Routes contractual documents for non-budget increase amendments

• Collaborate with Finance Specialists, Regulatory Affairs and Clinical Coordinators to ensure the negotiated budget terms are understood and billed correctly.

• Complete pre-award reviews using OnCore^TM and trains other finance team members in this task if required.

Additional Duties for Level II:

• Experience with clinical studies calendar specifications and protocol / subjected related procedures

• Works comprehensively with Clinical Project Managers and demonstrates advanced research budgeting knowledge.

Additional Duties for Level III

• Train oncology clinical trial budget Specialist I the clinical trials management software, OnCore^TM

• Train oncology clinical trial budget Specialist I budget management and negotiation.

• Train oncology clinical trial budget Specialist I budget calendar specifications and protocol / subjected related procedures

• Act as resource to assist other Clinical Research Budget Specialists as needed.

• Identify process improvement opportunities and involves others efficiently and effectively across interrelated teams to evaluate

Work Location:

Remote - this role is eligible to work remotely, but the employee must be in the United States.

Why Join Us:

The University of Colorado Cancer Center stands at the forefront of cancer research and patient care in Colorado. As the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center, we hold a prestigious distinction that acknowledges our exceptional contributions to the fields of research, clinical trials, prevention, and cancer control. Our guiding vision is clear: "prevent and conquer cancer. Together." At the heart of our mission is the work to "unite our community to overcome cancer through innovation, discovery, prevention, early detection, multidisciplinary care, and education."

Our more than 300 members, made up of renowned physicians and researchers, conduct patient-centered research to develop innovative, state-of-the-art technologies, and treatments. Crucial to this work is the nearly 300 staff members who help expand the reach of the CU Cancer Center. Our expertise across cancer types helps us provide world-class treatment for common cancers, while offering hope for many patients with difficult or aggressive cancers who have struggled to find treatment options elsewhere.

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.

To see what benefits are available, please visit: https://www.cu.edu/employee-services/benefits-wellness

Qualifications:

Minimum Qualifications:

Minimum Qualifications for Oncology Clinical Trial Pre Award Specialist I (Entry)

• Bachelor's degree from an accredited college or university in finance, business administration, healthcare or other related field.

Minimum Qualifications for Oncology Clinical Trial Pre Award Specialist II (Intermediate):

• Bachelor's degree from an accredited college or university in finance, business administration, healthcare or other related field.

• Two (2) years of professional experience working in Oncology Clinical Research Finance.

Minimum Qualifications for Oncology Clinical Trial Pre Award Specialist III (Senior)

• Bachelor's degree from an accredited college or university in finance, business administration, healthcare or other related field.

• Three (3) years of professional experience working in Oncology Clinical Research Finance.

Substitutions for all levels: Related experience in budget, finance, business administration or clinical field may substitute for the degree on a year for year basis.

Applicants must meet minimum qualifications at the time of application.

Preferred Qualifications:

Preferred Qualifications for Oncology Clinical Trial Pre Award Specialist I:

• Experience working with clinical trials management software, preferably OnCore^TM

• One (1) or more years' of experience working in a clinical or clinical research setting.

• Six (6) months or more experience reading and understanding clinical research protocols, specifically oncology is preferred.

• Experience managing budgets.

• Experience with clinical studies calendar specifications and protocol / subjected related procedures.

Knowledge, Skills and Abilities:

Knowledge, Skills and Abilities (All Levels):

• Good comprehension of contract terminology and confidence in own ability to draft and negotiate contract budget terms.

• Ability to work across different departments.

• Organizational skills, ability to multi-task, adapt to change, and handle competing priorities.

• Financial analytical skills, as well as the ability to troubleshoot problems and pursue resolutions.

• Critical thinking and decision-making skills with strong attention to detail

• Logic skills with the ability to learn and process large amounts of information and processes

• Excellent communication skills, both written and verbal.

• Familiarity with the concepts and practices related to medical and clinical research budgeting.

• Advanced knowledge of Microsoft Excel.

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 (only use if a cover letter is necessary)

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: Kari Mancillas, Kari.Mancillas@CUAnschutz.edu

Screening of Applications Begins:

Applications will be accepted until September 20, 2025.

Anticipated Pay Range:

The starting salary range (or hiring range) for this position has been established as HIRING RANGE (minimum - 40^th posting max).

Entry - $48,070-$61,145

Intermediate - $52,312-$66,541

Senior - $56,553-$71,936

If you have prior state-classified service in the same class series as this position, your pay may be set at a higher amount per the state Step Pay Program implemented on July 1, 2024. For more information about the Step Pay Program, please visit the 2024 Step Pay Program for State of Colorado Employees | DHR.

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: http://www.cu.edu/node/153125

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.