Pre-Award Specialist (Open-Rank)

University of Colorado•Hybrid, CO

4d•Hybrid

About The Position

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.

Requirements

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 (for Level II).
Three (3) years of professional experience working in Oncology Clinical Research Finance (for Level III).
Related experience in budget, finance, business administration or clinical field may substitute for the degree on a year for year basis.
Competent working with clinical trials management software, OnCore TM (for Level II).
Demonstrated increasing levels of experience managing budgets (for Level II).
Experience with clinical studies calendar specifications and protocol / subjected related procedures (for Level II).
Takes the initiative to assist other Clinical Research Budget Specialists as needed (for Level II).
Works comprehensively with Clinical Project Managers and demonstrates advanced research budgeting knowledge (for Level II).
Applicants must be legally authorized to work in the United States without requiring sponsorship. We are unable to provide work visa sponsorship and employment authorization for this position now or in the future.

Nice To Haves

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.
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.

Responsibilities

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