Research Business Specialist

Hackensack Meridian Health•Clifton, NJ

9d•Hybrid

About The Position

The Research Business Specialist provides support to Hackensack Meridian Health, Office of Research Administration, for pre/post award financial management of Clinical Trial research and ongoing support for the management of the Oncore Clinical Trial Management System (CTMS) across the HMH Network. This position will offer a hybrid schedule.

Requirements

Bachelor's degree in Accounting, Science, Healthcare or equivalent experience.
Minimum of 4 years of experience directly related to the duties and responsibilities specified.
Advanced Microsoft Office skills specifically in Excel.
Ability to analyze complex situations and identify solutions.
Ability to work effectively as a member of a team.
Effective written and verbal communication skills; excellent interpersonal skills.
Must be able to use basic office equipment.

Nice To Haves

Experience in clinical Research.
Experience with billing and collection processes.
Experience with Oncore CTMS or other CTMS systems.
Certified Clinical Research Professional.

Responsibilities

Conduct thorough analysis of research protocols to determine the specific protocol-required procedures, tests and timing of each procedure. High level review of the details of the schedule of events, along with the specific information in the procedural/visit descriptions and collaboration with study teams.
Create a schedule of events in the CTMS to reflect what is required by the protocol for accurate clinical trial data capture and financial tracking.
Develop a study-specific Excel workbook and send to research staff to collect information as needed.
Revise the CTMS calendar based on feedback from the study team or protocol amendments.
Enter budgets and all financial receivables in CTMS system and prepare invoicing as required by sponsor contracts.
Work with research study staff (Investigators, Coordinators, Project Managers, etc.) to review the study protocol and develop the study budget, including the billing grid and per-patient costs and entry of information into the OnCore CTMS application.
Obtain additional study related materials and contact sponsor for clarification as needed.
Review study budget with research staff to ensure all relevant study costs have been included.
Assist in developing all sponsored and internal sponsored clinical trials budgets/ Medicare Coverage Analysis.
For industry-sponsored studies, review contract payment terms and negotiate amounts with the sponsor as needed.
Ensure timely processing of all pre-award requirements in order to maintain a 90-day turnaround of sponsor documents.
Compare protocol and contract documents for consistency, specifically language in the Informed Consent document.
Acts as a liaison for HMH Network; attends finance meetings and assists other departments with global functioning details.
Update and maintain clinical trial contract and financial data in the OnCore system.
Update and maintain sponsor database and pre-award activity metrics.
Work to ensure a smooth transition between pre-award and post-award project phases, including transition to post-award accountants.
Renegotiate payments from sponsor and process contract and budget amendments as required by protocol amendments or input from PI/Coordinators/Data Analysts or Managers.
Assist with tracking of department financials including invoice and reconciliation processes. Monitor receipt of clinical trial payments from Sponsors.
Distribute clinical trial funds to its appropriate department and/or research accounts based on the internal budget.
Update research accounts and provides financial activity reports to the Principal Investigators and department Administrators.
Collaborate with fellow financial and contract administrators and others who work with clinical trials to develop best practices, standardize processes, document procedures, etc.
Works on special projects for HMH Office of Research Administration as assigned by leadership.
Other duties and/or projects as assigned.
Adheres to HMH Organizational competencies and standards of behavior.