Company: Guthrie
Job description: Job Category: Leadership/ProfessionalJob Description:Position SummaryThe Donald Guthrie Foundation for Research (DGF) is the research arm of The Guthrie Clinic and operates as a 501(c)(3) nonprofit organization. Its mission is to support, facilitate, and grow high-impact clinical, translational, and basic science research that enhances patient outcomes and improves healthcare delivery within the Twin Tiers community and beyond.This position represents the administrative dyad component of a physician-administrator leadership model. The dyad pairs the Executive Director of Research (physician leader-HPA) with a senior administrative executive to collaboratively lead the strategic, operational, and compliance functions of DGF. This role is central to ensuring the effective oversight of clinical research, human subject protections, data governance, educational research, and partnership development.The administrative executive has broad oversight responsibilities across core domains: * Clinical Research Operations in compliance and in regulatory areas.
- Supports research and scholarly activities related to Graduate Medical Education (GME), encompassing residents, fellows and medical students across Guthrie's 10 residency and 7 fellowship programs and clinical partnerships with GCSOM and LECOM.
- LEAP Testing Service accreditation (LTS)
- Master's degree required (MPH, MHA, MBA, or MS in STEM discipline).
- Minimum 3-5 years of direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA, NIH, or HHS.
- Minimum 5 years of experience in managing a clinical research organization
- Certifications in research administration (e.g., SOCRA, ACRP) preferred.
- At least 5 years of progressive leadership experience in research administration, higher education, or complex healthcare systems.
- Demonstrated success with program development, P&L accountability, strategic planning, and cross-functional implementation.
- Proven ability to lead and mentor high-performing teams.
- Deep understanding of human-subjects research compliance (AAHRPP, FDA, IRB, GCP, ICH).
- Experience in integrating clinical research into health system priorities and workflows.
- Knowledge of REDCap, regulatory software, and grant management tools.
- Experience partnering with physician investigators and clinical departments.
- Strong interpersonal, negotiation, and stakeholder engagement skills, especially in multidisciplinary environments.
- Experience coordinating with university research programs and navigating academic health partnerships.
- Work closely with the Organizational Official for the Federalwide Assurance (FWA) ensuring that The Guthrie Clinic fulfills its responsibilities under the FWA.
- Ensure IRB operations align with federal (OHRP, FDA), state laws and institutional policies. Provides guidance to the IRB in developing policies and procedures, interpreting regulations, obtaining Foundation Board approval of new IRB members, and executing recommendations of senior leadership and governing boards of The Guthrie Clinic.
- Assist Human Protection Administrator (HPA) by implementing rigorous oversight of human subject protocols, training programs, and IRB quality assurance processes. Assures that the IRB has appropriate resources to carry out its functions and that any additional reviews and approvals required by the organization are obtained before a research protocol involving human subjects can commence.
- Advises The Guthrie Clinic senior leadership on HRPP regulatory issues.
- Oversee FDA inspections, audits, AAHRPP accreditation, and documentation workflows to safeguard ethical research conduct.
- Serve as the Director of Research to align research priorities with Guthrie's strategic goals.
- Serve as the Research Integrity Officer to oversee academic integrity and development of procedures for investigating allegations of research misconduct.
- Oversight of sponsored research including investigational drug and device clinical trials
- Oversight of investigator-initiated research. Determine feasibility, scientific review, funding and resource allocation. Communicate directly with FDA for investigational new drug (IND) and investigational device exemptions (IDE), providing scientific expertise to the lead investigator.
- Lead initiatives in research data governance, REDCap implementation, and policy development.
- Develop and monitor program budgets, grant revenue, and research-related expenses.
- Manage pharmaceutical and federally funded study contracts, billing compliance, and audit preparation.
- Maintain dashboards to monitor research output, investigator activity, and financial performance.
- Ensure research is financially sustainable, integrated with clinical operations, and positioned for external funding.
- Strengthen collaborations with academic institutions including GCSOM, Binghamton University, LECOM, Cornell, and others.
- Support data-sharing agreements, MOUs, and joint research project development.
- Promote a culture of innovation and cross-disciplinary inquiry throughout Guthrie.
- Expand and oversee expansion and integration of pharmaceutical clinical research within other Guthrie entities.
- Lead the administrative support for GME-related research output.
- Collaborate with program directors, residents, fellows, and medical students to advance scholarly engagement and mentorship.
- Track metrics and outcomes related to GME academic research productivity.
- Build and maintain robust business processes for research operations, including project management, financial tracking, metrics reporting, and contract oversight.
- Implement quality improvement practices across all research functions.
- Serve as the primary liaison to internal leadership, Foundation Board members, and external stakeholders on all matters related to research operations.
- Support faculty development and mentoring to increase investigator-initiated research output.
- Lead infrastructure development to support new research lines, including community-based, implementation science, and translational studies.
- While in-person presence is preferred, the Administrative Executive may work remotely, with a flexible expectation of at least six on-site days per year to support key activities such as quarterly Board meetings, annual reviews, site visits, or other major events as needed.
- Standard office setting with regular use of computers and communication tools.
- Minimal exposure to safety hazards; no direct patient contact.
- Hybrid or remote flexibility may be considered based on organizational needs.
- Daily engagement with staff across clinical, educational, and administrative domains.
- Regular interaction with academic institutions, regulatory agencies, industry sponsors, and community partners.
- Participating in data collection and evaluation.
- Contributing to improvement teams and initiatives.
Expected salary:
Location: Sayre, PA
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