You are viewing a preview of this job. Log in or register to view more details about this job.

Clinical Trials Budget Specialist

Description

 
University of Colorado | CU Anschutz Medical Campus
Department of Medicine, Division of Gastroenterology and Hepatology
Clinical Trials Budget Specialist (Research Services Senior Professional) 
Position #00002390 – Requisition #19051
 
* Applications are accepted electronically ONLY at www.cu.edu/cu-careers *
 
The Department of Medicine, Division of Gastroenterology and Hepatology has an opening for a full-time University Staff (unclassified) Clinical Trials Budget Specialist position. 

The University of Colorado’s Division of Gastroenterology and Hepatology in the Department of Medicine, located at the Anschutz Medical Campus, is an internationally renowned program digestive tract, pancreas and liver. The Division of Gastroenterology and Hepatology has faculty and staff making contributions to research, clinical trials, and nationally recognized patient care. Gastroenterology & GI Surgery is one of the top ranked in the United States and our clinical partner, the University of Colorado Hospital, and is in the top hospitals nationwide as ranked by U.S. News and World Report. The Division of Gastroenterology and Hepatology is rapidly growing, with clinical practices throughout the state of Colorado and over 80 researchers, physicians and staff, all working toward its vision to prevent and treat disease while being a global model for patient care delivery, interdisciplinary research, and training.
 
Nature of Work
Reporting to the Division Administrator, this position is responsible for overseeing the pre-award process for clinical trials in the Division Gastroenterology and Hepatology to ensure the successful development, negotiation and finalization of budgets and contracts for clinical research trials conducted by members of the Division of Gastroenterology and Hepatology. This position will also assist the Division Administrator in all aspects of clinical trials budgets; including forecasting and financial reporting. In close collaboration with Principal Investigators (PIs) and division research staff, this position will prepare clinical trial budgets and billing plans, negotiate with industry sponsors, route agreements for institutional approvals, and process contract amendments. The position will make recommendations on modifying division fees, policies, and procedures related to clinical trial administration. 
 
Examples of Work Performed
  • Prepare sponsored programs budgets. Serve as a trusted advisor to PIs on budget restrictions, direct/indirect cost rates, and other budgetary factors based on University and sponsor guidelines.
  • Serve as a primary liaison between sponsors, principal investigators, and departments. When possible, work with sponsors to negotiate the terms and conditions of awards that are most advantageous for the university and the researcher(s).
  • Stay up to date on all new and evolving institutional changes as they relate to policy, pricing, budgeting, etc. for clinical trial data captured in OnCore.
  • Work with OnCore calendar builders to ensure financial information in OnCore, accurately portrays rates and prices in the negotiated budgets in accordance with the terms of the protocol. 
  • Review contractual documents to ensure final negotiated terms have been incorporated. 
  • Execute clinical trial budgets by working with industry sponsors and corresponding institutions such as UCHealth, CU Medicine, CCTSI, OnCore, Regulatory Compliance, etc. 
  • Review, draft and negotiate a variety of sponsored project, revenue, and other related contracts. Ensure compliance with University, state, and federal policies and regulations.
  • Prepare institutional forms and coordinate process for internal approval ("routing") of application to meet Office of Grants and Contracts (OGC) requirements. 
  • Maintain accurate and timely task tracking sheets on incoming studies and amendments. 
  • Create, maintain, and update division procedures for all pre-award processes. 
  • Provide advice, consultation and expertise to division leadership, research staff and faculty members regarding the viability of a proposed clinical trial.
  • Serve as a liaison between the Sponsor/Subcontractor and University related to contracts.
  • Provide back-up coverage to the Clinical Trials Billing and Finance Coordinator (post-award). 
  • Understand negotiated budgets and terms, periodically reviewing study progress including patient enrollment information, and generating accurate and timely invoices to the sponsor, as requested.
  • Present at weekly division research meetings as requested. 
  • Other duties as assigned. 
This description is a summary only and is describing the general level of work being performed, it is not intended to be all-inclusive. The duties of this position may change from time to time and/or based on business need. We reserve the right to add or delete duties and responsibilities at the discretion of the supervisor and/or hiring authority.
 
Salary and Benefits:
 
Salary is negotiable and commensurate with skills and experience. This position is not eligible for overtime compensation.
 
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.
  
 
Diversity and Equity:
 
The University will provide reasonable accommodations to applicants with disabilities throughout the employment application process. To request an accommodation pursuant to the Americans with Disabilities Act, please contact the Human Resources ADA Coordinator at hr.adacoordinator@ucdenver.edu
 
The University of Colorado | Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities and all veterans. The University of Colorado is committed to diversity and equality in education and employment.
 
The University of Colorado | Anschutz Medical Campus is dedicated to ensuring a safe and secure environment for our faculty, staff, students and visitors. To assist in achieving that goal, we conduct background investigations for all prospective employees. 
 

Qualifications

 
Minimum Qualifications:
  • A bachelor’s degree in public health, public administration, social/behavioral sciences, physical sciences, nursing, healthcare, finance, accounting, business administration, business, or a directly related field from an accredited institution.
  • Two years’ experience in research, finance, and/or a business-related position.

Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor’s degree on a year for year basis, but not for the specific experience.

 
Preferred Qualifications
  • Experience with clinical research in an academic setting. 
  • Experience with the construction and submission of clinical trial agreements.
  • Experience working with clinical trials management software, preferably OnCore
  • Experience managing budgets.
  • Experience with contract negotiation.
  • Experience with CU Systems (e.g. InfoEd, HCM, mFIN, CU-Data, and Marketplace.  

Competencies (Knowledge, Skills, and Abilities)
  • Ability to communicate effectively, both in writing and orally. 
  • Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
  • Outstanding customer service skills.
  • Demonstrated commitment and leadership ability to advance diversity and inclusion.
  • Knowledge of the regulatory landscape associated with the construction and submission of clinical trial agreements (e.g. HIPAA, human subject protection, Grants and Contracts, IRB, and university policies and procedures).
  • Ability to effectively manage time with the ability to prioritize multiple, ongoing projects. Skilled in managing competing priorities and shifting deadlines.
  • Ability to work independently, be self-motivated, and detail oriented. 
  • Ability to interpret complex rules, regulations, policies, procedures, and guidelines.
  • Ability to work independently and as a team member with diverse faculty, staff, and student populations.
 
 
Special Instructions to Applicants: Required Application Materials: To apply, please visit: http://www.cu.edu/cu-careers and attach: 1. A letter of application which specifically addresses the job requirements and outlines qualifications 2. A current CV/resume 3. List of three to five professional references (we will notify you prior to contacting both on and off-list references) 4. Additional Attachments Questions should be directed to: Spencer.LaFasto@cuanschutz.edu
 
 Application Materials Required: Cover Letter, Resume/CV, List of References
 
Application Materials Instructions: Application Deadline: Applications are accepted electronically ONLY at www.cu.edu/cu-careers. Applications will be accepted until finalists are identified, but preference will be given to complete applications received by October 12th, 2020. Those who do not apply by October 12th, 2020, may or may not be considered.
 
 
Job Category: Research Services
 
Primary Location: Aurora
 
Department: U0001 -- DENVER & ANSCHUTZ MED CAMPUS - 20189 - SOM-MED-Gastroenterology
 
Schedule: Full-time
 
Posting Date: Aug 20, 2020
 
Unposting Date: Ongoing
 
Posting Contact Name: Specner LaFasto
 
Posting Contact Email: Spencer.LaFasto@cuanschutz.edu
 
Position Number: 00002390