Director- Innovation & Research

Deadline to apply: Until filled

Key Areas of Responsibility:

1. Sponsored research and clinical trials, including business development, study-start-up, clinical trial agreement and budget negotiation, regulatory compliance, recruitment, enrollment, trial execution.
2. Service line research development, including alignment of sponsored research and grant activities with service line growth, KH business relationships, and KH strategic priorities.
3. Grants and sponsored programs administration, including identifying appropriate funding opportunities, project development, research development, grant application preparation and submission, funding agency relationships, Uniform Guidance compliance, and all post-award activities.

The system director for Innovation, Research & Grants (IRG) provides direction and oversight for sponsored research initiatives conducted within KHN and in association with collaborative research partners. Also, the director oversees program and project grants with local, regional, national and international industry partners, local and regional universities, and governmental agencies. The director fosters a collegial and supportive environment to ensure research and grant projects are conducted in an ethical manner with fidelity to scientific inquiry while protecting the rights and welfare of study participants. The director is responsible for oversight in the day-to-day conduct of research operations per IRG-developed policies and procedures, regulatory compliance and reporting, and grant administration. The director collaborates with the research team to assess the feasibility and appropriateness of potential research trials under consideration from industry-sponsored pharmaceutical and device partners, KHN investigators, and community researchers. The director is also responsible for all grant compliance with funder terms and conditions and for publicly funded grants, compliance with the federal Uniform Guidance.

The director is responsible for positive communication processes both internally and externally as to the services provided by the office of IRG including the comprehensive training of investigators and research team members on the study plan and the requirements for timely reporting of any protocol deviations. The director ensures all regulatory requirements associated with clinical trial protocol implementation and periodic reporting are provided to the respective Institutional Review Board(s) and Conflict of Interest Committee per KHN policies, and the required reporting delineated in the Code of Federal Regulations governing research (CFR Title 21) is thorough and accurate. In addition, the director is responsible for ensuring compliance with all Kettering Health policies related to the conduct of research and performance of grant projects. The director leads business development efforts to enhance industry and government agency relationships to sustain and expand our research portfolio. The director of IRG is responsible for business development for clinical trials and other funded research opportunities. The director also collaborates with service line and clinical executives and leaders across Kettering Health to align all research and grant activities with system strategy and priorities.

The director works collaboratively with the research team to set the departmental strategic plan and individual employee goals, providing evaluation of progress toward these goals, supporting the professional growth of staff. Department employees under the direct supervision of the director: manager of grants administration; manager of research operations; and manager of research finance.

• The director works with the manager of research finance in the creation of the department budget with tracking of revenues and expenditures in line with the approved budget while providing oversight to ensure sound financial principles are applied to all grant-funded research and clinical These activities include clinical trial budget building, CMS compliance for clinical trial billing, and fair market value assessment for research activities including physician compensation.
• The director works with the manager of research operations to enable efficient trial execution maximizing staff productivity, enhancing revenues, and minimizing trial Oversight of operations also includes ensuring compliance with FDA, HHS, and CMS regulations related to research.
• The director works with the manager of grants administration to identify funding opportunities that are aligned with system strategic priorities, assist in developing competitive applications, and oversee post-award compliance with the Uniform Guidance. This includes grant project budget development, expense tracking, general ledger reconciliation, and preparing requests for funding agency drawdown of funds.

The director provides timely reporting on any concerns of research misconduct and changes in compliance laws, regulations, policies, and statutes with respect to the conduct of research. The main objective of conducting funded research, beyond patient benefit, is to grow revenue to reinvest in internal unfunded programs. An area of great need is graduate medical education: faculty, fellow, and resident support for academic research and scholarly activity. The director of IRG works closely with the director of research integrity, academic research, and medical libraries to consolidate and enhance all research functions across the system and build collaborative infrastructure to support investigator-initiated research projects. Full integration of KH research functions will ultimately result in "one door to research" for the entire system.

The system director of IRG must possess an ability to think strategically, delegate responsibility, listen carefully, build consensus and communicate and advocate effectively for research activities in support of the mission of KH - to improve the lives of the people in the communities in which we serve. The director must be willing to share credit for successes and encourage the integration of others' ideas and proposals. The director will foster the development of the research team and exhibit a commitment to exceptional research operations and excellent grants administration. The director must possess unquestioned integrity, honesty and a sense of humor. Performs other duties as assigned.

Minimum Education

• Doctoral Degree required preferably in a health science or related field. 

Required Skills

• Expertise in the conduct of research as detailed in the International Conference on Harmonization and Good Clinical Practice, ICH E6, E2A and E8. Code of Federal Regulations (CFR) Title 21, Parts 11, 50, 54, 56, 312, 314
• Knowledge of financial cost principles governing receipt and management of private and public monies (grant funding) for research and other projects
• Expertise in clinical trial agreement development and negotiation of research budgets
• Working knowledge of the clinical care provided in care settings where research is conducted.
• Expertise in pre-award grant application preparation and submission.
• Expertise in Uniform Guidance 2 CFR 200, federal regulations, and post-award administration related to public and private funds.

Minimum Work Experience

A minimum 5 years' experience in pharmaceutical and/or industry-sponsored studies with a minimum 3 years' direct experience in clinical research operations and oversight. Minimum 3 years’ experience in federal contract and grant funding administration

Required Licenses

• HRP (Human Research Protection Training) COI (Conflict of Interest for Research)
• RCR (Responsible Conduct of Research)
• CITI Health Information Privacy and Security (HIPS) for Researchers

Essential Functions 

• Promote research activities throughout KH by supporting an environment of scientific inquiry among medical staff, employees, and community partners.
• Support investigators in the development of research protocols/projects and related financial narratives and
• Provide researchers with the resources and oversight to conduct sound clinical trials consistent with all applicable regulations and requirements.
• Develop and execute study agreements, contracts and budgets with research
• Oversee collaborative relationships between IRG, academic research and research integrity.
• Ensure departmental operations are consistent with sound research operating principles and research team members are competently trained.
• Monitor departmental fiscal operations to ensure compliance with KHN-approved budget with attention to unallowable, direct, and facilities and administrative (F&A)
• Oversee grants administration including project development, research development, grant application preparation and submission, and all post-award activities.
• Ensure state of readiness in preparation for all monitoring activities and audits from study sponsors and/or FDA 

Leadership Capabilities

• Communication with team, leadership, sponsors
• Collaboration with service lines, ancillary departments, community partners
• Business development (industry connections, sponsor network, site networks, grant opportunities
• ACRP-CP (Association of Clinical Research Professionals Certified Professional) preferred