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A cover letter and resume are required for consideration for this position.  The cover letter should specifically address your interest in this position and outline particular skills and experience directly related to this position.

Job Summary

As part of the strategic research initiative, Fast Forward Clinical Trials (FFCT) is engaging the entire UMHS in creating a new model to improve clinical care, value, and health outcomes by successfully executing a diverse portfolio of high-quality clinical trials. This new model entails an organizational structure of local clinical trial support units (CTSU’s), central infrastructure, and governance oversight. The CTSU’s are trans-departmental and thematically aligned based on research foci. CTSU’s are the local groups that provide comprehensive pre and post award support to study teams, offering high-quality efficient service in support of a mix of clinical trials. These support units will provide a professional environment of expert personnel accessible to all investigators, especially early-career faculty. The Medical School Office of Research and Michigan Institute for Clinical and Health Research (MICHR) are responsible for central services, providing enterprise-wide standards, policies and common infrastructure that can be leveraged by the support units and study teams. The entire system is governed by the Medical School Office of Research in partnership with the Clinical Trials Subcommittee of the Research Board of Directors. The Research Process Coordinator will be a float position providing pre award support for difference CTSU’s depending on need.

Responsibilities*

Support physician-investigators who conduct clinical trials initiated by industry, consortia, cooperative groups, or investigators themselves through Clinical Trials Support Units. Dissect protocol; identify and represent treatment items and services on billing calendar. Review consent, protocol, study calendar and budgets to ensure alignment and capture all applicable items and services. Meet with PI to determine payment responsibilities (insurance v. study). Provide direction to PI regarding accounting and budgeting responsibilities. Interface as needed with study team and stakeholders (CTSU, Research Pharmacy, MBECT/OnCore, MCRU, Departments, Medical School, ORSP) regarding study needs and logistics. Prepare and negotiate study budgets, payment terms, and certain contract items with sponsors. Facilitate internal review process. Prepare PAF and route in eResearch Proposal Management System (eRPM). Maintain internal logs and records. Build and maintain clinical trial and budget information in the clinical trial management system, OnCore. 

Required Qualifications*

Bachelor’s degree. Minimum three years’ experience in finance and/or research setting. Ideally, strong acumen in budgeting for clinical trials. Ability to manage multiple deadlines and high-priority projects simultaneously. Excellent analytical skills and keen attention to detail. Strong organizational skills and a record of timely delivery and high quality work/results. Excellent verbal and written communication skills. Ability to think critically, analyze, interpret, and problem solve in order to offer solutions. Able to work independently but also in a team dynamic. 

Desired Qualifications*

Certification in SoCRA or ACRP. Previous experience developing budgets for clinical trials. Experience in clinical trial conduct at the University of Michigan; familiarity with internal processes and systems (MPathways, eResearch, Velos/OnCore).

Work Schedule

Position pays at least $25/hr., M-F, 8:00am-4:30pm. Assignment begins 01/07/2019 and is expected to last 3-6 months.
 

U-M EEO/AA Statement

The University of Michigan is an equal opportunity/affirmative action employer.