Pre-Award Specialist (Open-Rank)

University of Colorado; United States; Hybrid; USD 80,000 - 110,000; Full time

Job summary

University of Colorado Cancer Center at Anschutz Medical Campus seeks a Pre-Award Specialist (Open-Rank) to develop, negotiate, finalize and review budgets for oncology clinical trials. This hybrid role collaborates with industry sponsors, CU finance, clinical staff, and regulatory teams to ensure compliant, cost-effective budgets and contracts.

The position requires learning MCA concepts, oncology trial protocols, and CU Medicine processes, with extensive training provided.

Qualifications

• Budget development, negotiation and review in clinical trials.
• Familiarity with Medicare Coverage Analysis (MCA) and oncology trial protocols.
• Experience with contracting, grants and regulatory compliance.

Responsibilities

• Review clinical trial protocols to draft study-specific budgets accounting for procedural and labor costs.
• Negotiate budgets with industry sponsors.
• Review and negotiate contractual payment terms.
• Collaborate with CRAO to review and approve final contracts (budget sections).
• Work with OnCore calendar builders to reflect negotiated budgets in OnCore.
• Review documents to ensure negotiated terms are included.
• Route documents for non-budget increase amendments.
• Collaborate with Finance Specialists, Regulatory Affairs and Coordinators to ensure budgeting terms are billed correctly.
• Complete pre-award reviews using OnCore and train others as needed.
• Additional duties for Level II: work with trial calendars and advanced budgeting knowledge.
• Level III: train others on OnCore budget management and act as a resource.

Job description

University of Colorado Anschutz Medical Campus

Department: Cancer Center

Working Title: Pre-Award Specialist (Open-Rank)

Position #: 00709146 - Requisition #: 41441

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 (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:

Hybrid - this role is eligible for a hybrid schedule of #3 days per week on campus and as needed for in-person meetings.

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 offeri