Pre-Award Specialist (Open-Rank)

University of Colorado•Colorado Springs, CO

7d•$50,160 - $75,063•Hybrid

About The Position

The Oncology Clinical Research Pre-Award Specialist develops, negotiates, finalizes, and reviews budgets for clinical trials conducted by University of Colorado Cancer Center faculty at University of Colorado Hospital. The role requires discretion, analytical skill, personal responsibility, and the ability to identify and resolve problems collaboratively and creatively while adhering to system, institutional, and state fiscal policies. The specialist works with pharmaceutical companies, finance contacts, clinical staff, faculty, hospital and university administrative staff, and CU Medicine representatives. The position receives extensive training in Medicare Coverage Analysis, oncology trial protocols, clinical trial processes, and the work of post-award, finance/billing, and clinic teams. Duties include reviewing complex oncology protocols, preparing study-specific budgets covering procedural and labor costs, and working with OnCore, calendar builders, and project/research managers to ensure costs are accurately represented. The specialist also supports contract and grant solicitation and administration, agreement preparation, review and negotiation, regulatory compliance, sponsor communication, and pre-award management. The role has budgetary oversight and advances oncology trial contracts and amendments sponsored by industry, cooperative groups, federal grants and contracts, and investigator-initiated trials. This is an open-rank position with entry, intermediate, and senior levels. The intermediate and senior levels include additional responsibilities related to clinical-study calendars, advanced budgeting, training, serving as a resource to colleagues, and identifying process improvements. The position follows a hybrid schedule with three days per week on campus and additional in-person attendance as needed.

Requirements

A bachelor's degree from an accredited institution in finance, business administration, healthcare, or a related field for all levels; related experience in budgeting, finance, business administration, or a clinical field may substitute for the degree on a year-for-year basis.
For the intermediate level, at least two years of professional experience in Oncology Clinical Research Finance.
For the senior level, at least three years of professional experience in Oncology Clinical Research Finance.
For the intermediate level, competent experience working with clinical trials management software, OnCore.
For the intermediate level, demonstrated increasing experience managing budgets.
For the intermediate level, experience with clinical study calendar specifications and protocol-related procedures.
For the intermediate level, initiative in assisting other Clinical Research Budget Specialists and the ability to work comprehensively with Clinical Project Managers using advanced research budgeting knowledge.
Good comprehension of contract terminology and confidence drafting and negotiating contract budget terms.
Ability to work across different departments.
Organizational skills, ability to multitask, adapt to change, and manage competing priorities.
Financial analytical skills and ability to troubleshoot problems and pursue resolutions.
Critical-thinking and decision-making skills, with strong attention to detail.
Ability to process large amounts of information and learn complex processes.
Excellent written and verbal communication skills.
Familiarity with concepts and practices related to medical and clinical research budgeting.
Advanced knowledge of Microsoft Excel.
Legal authorization to work in the United States without current or future visa sponsorship.
Ability to work a hybrid schedule, including three days per week on campus.

Nice To Haves

Experience with clinical trials management software, preferably OnCore, for the entry-level qualification.
At least one year of experience working in a clinical or clinical research setting.
At least six months of experience reading and understanding clinical research protocols, preferably oncology-related.
Experience managing budgets.
Experience with clinical study calendar specifications and protocol-related procedures.

Responsibilities

Review clinical trial protocols and draft study-specific budgets that account for procedural and labor costs.
Negotiate budgets with industry sponsors.
Review and negotiate contractual payment terms.
Work with the Clinical Research Administration Office to review and approve final contracts, including budget-related sections and exhibits.
Work with OnCore calendar builders to ensure that financial information accurately reflects procedures, rates, and prices in negotiated budgets.
Review contractual documents to confirm that final negotiated terms have been incorporated.
Route contractual documents for amendments that do not increase the budget.
Collaborate with Finance Specialists, Regulatory Affairs, and Clinical Coordinators to ensure negotiated budget terms are understood and billed correctly.
Complete pre-award reviews using OnCore and train other finance team members in this task when required.
At the intermediate level, work with clinical study calendar specifications and protocol-related procedures, and work comprehensively with Clinical Project Managers using advanced research budgeting knowledge.
At the senior level, train Specialist I staff in OnCore, budget management and negotiation, and budget calendar specifications and protocol-related procedures.
At the senior level, serve as a resource to other Clinical Research Budget Specialists and identify process improvement opportunities in collaboration with interrelated teams.