The Medical College Of Wisconsin

posted about 2 months ago

Full-time - Mid Level
Remote
Educational Services

About the position

In the role of a Grants Operations Coordinator at the Medical College of Wisconsin (MCW), you will be integral to the Cancer Center's operations, focusing on the pre-award planning, organization, and preparation of clinical trial contracts and protocol amendments. This position requires you to interact with various stakeholders, including CTO managers, investigators, pharmaceutical representatives, MCW grant office analysts, third-party vendors, and other institutional partners. Your primary goal will be to ensure that clinical protocols are processed within service standard timelines while adhering to regulatory, funding agency, and policy requirements. As the CTO budget and contract point of contact for a specified clinical trial portfolio, you will interpret and articulate both institutional and sponsor policies and relevant procedures to ensure compliance. You will proactively inform stakeholders of any changes in clinical trial policies and regulations from relevant trial sponsors. Collaborating with departments and central administrative offices will be essential to achieve compliance and timely execution of study agreements. Your responsibilities will include reviewing clinical trial protocols and clinical trial agreements (CTAs) for redline changes, preparing detailed study budgets for new studies or amendments, and submitting these for budget and contract negotiation. You will also assist in the preparation of final Clinical Trial agreements and sponsor-negotiated budgets for submission in eBridge. Negotiating terms and conditions of externally funded clinical trials will be part of your role, along with escalating any budget or contract concerns to CC leadership or the Principal Investigator (PI) for resolution. Additionally, you will be responsible for the development and finalization of OnCore Financial Billing Grids, which include billing designations and CPT codes, to facilitate tracking and billing of study sponsors. Partnering with other MCW Cancer Center finance/CTO team members on team-based projects will also be part of your duties, ensuring compliance with sponsor terms, MCW policies/procedures, and federal regulations.

Responsibilities

  • Coordinate the pre-award planning, organization, and preparation of clinical trial contracts and protocol amendments.
  • Serve as the CTO budget/contract point of contact for a specified clinical trial portfolio within the Cancer Center CTO with the GCO.
  • Interpret and articulate both institutional and sponsor policies and relevant procedures to ensure compliance.
  • Proactively inform stakeholders of changes in clinical trial policies and regulations of relevant trial sponsors.
  • Review clinical trial protocols and clinical trial agreements (CTAs) for redline changes and prepare detailed study budgets for new studies or amendments.
  • Assist in the preparation of final Clinical Trial agreements and sponsor-negotiated budgets for submission in eBridge.
  • Negotiate terms and conditions of externally funded clinical trials and escalate budget or contract concerns to CC leadership or the PI for resolution.
  • Develop and finalize OnCore Financial Billing Grids and financial builds to facilitate tracking and billing of study sponsors.
  • Partner with other MCW Cancer Center finance/CTO team members to participate in team-based projects as assigned.
  • Ensure compliance with sponsor terms, MCW policies/procedures, and federal regulations.

Requirements

  • Bachelor's degree in a relevant field.
  • Minimum of 4 years of experience in grants operations or a related field.
  • Knowledge of biology, chemistry, mathematics, documentation, and records management.
  • Strong data utilization, complex problem-solving, critical thinking, resource management, and writing skills.

Nice-to-haves

  • Experience in clinical trial budget and contract development.

Benefits

  • Outstanding Healthcare Coverage including Health, Vision, and Dental.
  • 403B Retirement Package.
  • Competitive Vacation and Paid Holidays offered.
  • Tuition Reimbursement.
  • Paid Parental Leave.
  • Pet Insurance.
  • On-campus Fitness Facility offering onsite classes.
  • Discounted rates on select cell phone plans, local fitness facilities, and Milwaukee recreation and entertainment.
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