Pre-Award Specialist; -Rank

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. The position requires discretion, analytical skill and personal responsibility to identify, research, collaborate and creatively solve problems in a changing environment while remaining within system, institutional, and state fiscal policies.

This role works extensively with individual pharmaceutical companies, CU finance contacts, clinical staff, faculty members, the University of Colorado Hospital, administrative staff throughout the University, and representatives from various departments and CU Medicine. The position requires training on 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, and clinic staff.

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

• 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 to review and approve final contracts (budget related sections and exhibits).
• Work with OnCore calendar builders to ensure financial information in OnCore accurately portrays procedures, rates and prices in the negotiated budgets.
• Review contractual documents to ensure final negotiated terms have been incorporated.
• Route 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 and train other finance team members in this task if required.

• Experience with clinical studies calendar specifications and protocol / subject‑related procedures.
• Works comprehensively with Clinical Project Managers and demonstrates advanced research budgeting knowledge.

• Train oncology clinical trial budget Specialist I in the clinical trials management software, OnCore.
• Train oncology clinical trial budget Specialist I in budget management and negotiation.
• Train oncology clinical trial budget Specialist I in budget calendar specifications and protocol / subject‑related procedures.
• Act as resource to assist other Clinical Research Budget Specialists as needed.
• Identify process improvement opportunities and involve others efficiently and effectively across interrelated teams to evaluate.

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

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…