Pre-Award Specialist (Open-Rank)

University of Colorado Anschutz Medical Campus

Department: Cancer Center

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

Position #: 00734292 – Requisition #: 39935

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, OnCoreTM, 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 OnCoreTM calendar builders to ensure financial information in OnCoreTM, 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 OnCoreTM 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