Director Pediatric Neurology Research - Pediatrics Specialist- - Full-time

Rush University Medical Center•Chicago, IL

57d•$52 - $78•Onsite

About The Position

Under the general direction of the Department Administrator of the Rush Children's Hospital (Pediatrics), the Director of Pediatric Neurology Research will be responsible for the overall fiscal, regulatory, operational, administrative, and personnel management of the Pediatrics Neurology research division. This responsibility includes overseeing a broad range of clinical trials, consortia studies, as well as both single- and multi-site industry, federal, foundational, and philanthropic research projects. The individual who holds this position exemplifies the Rush mission, vision, and values and acts in accordance with Rush policies and procedures.

Requirements

Bachelor's degree required.
At least 8 years of related clinical research experience required
Demonstrated expertise in NIH and industry-sponsored phase I-IV clinical trials protocols and procedures.
Proficient in the Microsoft Office Suite.
Demonstrated organizational and leadership skills.
Excellent written and verbal communication skills.
Ability to motivate multidisciplinary teams.
Ability to work effectively with individuals at all levels of the organization.
Ability to create, negotiate, and monitor various types of study budgets.

Nice To Haves

Master's degree preferred.
10-15 years of related clinical research experience preferred.
8 years of prior supervisory experience preferred.
Experience in research administration preferred.

Responsibilities

Provides executive oversight for contracting, regulatory, and budgeting processes involving external stakeholders, the Office of Research Affairs, and Research Revenue Cycle, including all steps required to move a potential new project from inception - initial feasibility, contract and budget negotiation, coverage analysis, ancillary committee reviews, and IRB approval - through the duration of the study, along with closeout and reconciliation. Projects consist of various funding sources (industry, foundation, federal, philanthropic, or combination thereof), study types (interventional, natural history, registry, etc.), interventions (drug, device, behavior), IRBs (local, external), and reimbursement structure (fixed rate, cost-reimbursable).
Leads collaboration with the Director of Finance as well as representatives in Fund Accounting, Research Revenue Cycle, and Sponsor Invoicing to manage the fiscal portfolio, which includes research revenue projections, fiscal year budget projections, review and approval of study-related expenditures, resource and staffing allocation, invoicing, and revenue collection. Also responsible for addressing queries related to portfolio-associated activities, revenues, and expenditures.
Directs site level engagement and participation in federally funded consortia, including but not limited to participation in working groups, committees, conference attendance, and study selection and execution.
Directs contracting, regulatory, budgeting, staffing allocation and oversight, local site investigator and study selection, as well as administrative aspects of maintaining required clinical common data models and query resolution.
Directs the pre- and post-award processes for research grants and contracts, including proposal development, award setup, and reporting
Provides executive oversight for the coordination of all Pediatric Neurology Research division, including industry-, NIH-, other federal (CDC and DOD), and foundation- clinical trials, natural history studies, registries, and others as needed
Provides executive oversight for the resource planning and allocation of the staff working in the Pediatric Neurology Research division and volunteers including hiring, training, study assignments, and dismissals.
Provides executive oversight of Clinical Research Regulatory Compliance Manager and Clinical Research coordinator leads, who work closely with study Principal Investigators and assigned staff to initiate and complete all activities during the course of a study including, from study start up to close.
Directs the implementation of procedures to monitor and audit compliance of operations with standards of Rush University and other outside regulatory bodies including, but not limited to, the United States Food and Drug Administration (FDA), the Department of Health and Human Services (DHHS), and the Office of Human Research Protection (OHRP).
Champions collaboration with the Principal Investigators, key personnel of the Outreach and Education, Clinical Services, Population Studies, Administration, and Laboratory divisions of the Pediatrics Department in the development of tools necessary to support ongoing operations of Pediatrics' Neurology research.
Leads engagement with key personnel in ancillary services departments (including, but not limited to, radiology, cardiology, ophthalmology, rheumatology, MS, laboratory services, and multiple on-site pharmacies) to nurture research-oriented relationships and foster smooth operational transfers across various departments.
As a member of Pediatrics' leadership, develops, reviews, and monitors compliance with departmental policies and procedures.
Directs the design and development of electronic tools and reports necessary to track the operational progress and guide allocation of resources required to oversee the day-to-day operations of the portfolio of Patient-Oriented Research + Design.
Manage and oversee all operations of the FAST Center, including budget development and fiscal reporting, ensuring compliance with institutional and regulatory guidelines, recruiting and supervising research staff, and coordinating procurement of supplies and resources to support ongoing research and administrative activities.
Other duties as assigned.