CEO Executive AssistantClinical and translational research is a defining function of academic medical centers and an increasingly important capability for health systems seeking to differentiate their clinical programs, attract specialized physicians, and contribute to the evidence base that shapes healthcare practice. For CEOs leading research-intensive health systems, academic medical centers, or organizations building research capabilities, the operational demands of clinical research are substantial and distinct from clinical care delivery. Research operations require compliance systems, financial management approaches, and oversight structures that most healthcare operational frameworks do not address with sufficient depth.
This guide outlines how healthcare CEOs can build the operational infrastructure needed to support high-quality, compliant clinical research at scale, from IRB governance and study start-up operations to grant management, research finance, and research compliance.
The CEO’s Role in Research Operations
Strategic Vision for Research
Healthcare CEOs must articulate a clear strategic vision for research that defines the organization’s ambitions, target areas of scientific focus, and investment commitments. Research strategy shapes recruitment priorities for physician-scientists, capital investment in research infrastructure, and the organization’s positioning with academic partners, funding agencies, and industry sponsors.
Research strategy decisions that require CEO-level clarity include:
Research portfolio focus. Organizations that concentrate research investment in defined therapeutic areas, patient populations, or scientific disciplines build depth of expertise, attract specialized talent, and generate meaningful scientific output more effectively than those that pursue research breadth without adequate resources.
Industry vs. federal funding balance. NIH and other federal grants provide non-commercial funding that supports investigator-initiated research and generates peer-reviewed publications. Industry-sponsored clinical trials provide revenue that funds research infrastructure and contributes to the evidence base for new therapies. CEOs must define the intended balance between these funding types and build the operational capabilities to compete in each channel.
Research-to-clinical translation pathways. The ultimate value of health system research is its translation into improved clinical care. CEOs who build deliberate pathways from research discovery to clinical protocol implementation create competitive advantages in clinical program development that are difficult for competitors without research infrastructure to replicate.
Research Governance and Oversight
Healthcare organizations conducting human subjects research must maintain governance structures that protect research participants and ensure the integrity of research data. CEOs must understand these governance requirements and ensure the organizational infrastructure to support them is adequate:
Institutional Review Board (IRB). The IRB is the primary ethical oversight body for human subjects research. CEOs must ensure their IRB is properly constituted, independently resourced, and empowered to make decisions that prioritize participant protection over commercial or productivity pressures. An IRB that is under-resourced or that experiences inappropriate influence over its decisions creates significant regulatory, legal, and reputational risk.
Research Compliance Office. A dedicated research compliance function monitors adherence to federal research regulations, institutional policies, and sponsor requirements. CEOs should ensure the research compliance office has direct access to senior leadership and sufficient staffing to provide meaningful oversight of the research portfolio.
Conflict of Interest management. Federal regulations and institutional policies require disclosure and management of financial conflicts of interest in research. CEOs must ensure the organization’s conflict of interest review processes are robust, that disclosures are reviewed by an independent committee, and that management plans are implemented and monitored.
Research Operations Infrastructure
Study Start-Up Operations
The time from study activation to first patient enrollment is a critical operational metric for clinical research. Sponsors evaluate site performance based on start-up timelines, and faster start-up generates earlier revenue and demonstrates operational competence that attracts future studies. CEOs should invest in study start-up operations as a competitive capability:
Contract and budget negotiation. Each industry-sponsored clinical trial requires a clinical trial agreement and budget negotiated between the site and the sponsor. CEOs should ensure contract and budget negotiation functions are staffed adequately, that turnaround time expectations are set and monitored, and that negotiated budgets recover the full cost of study conduct.
Regulatory document management. Study activation requires assembling and maintaining a regulatory binder with IRB approvals, investigator CVs, training documentation, and other required documents. Digital regulatory document management systems reduce administrative burden and support multi-site regulatory document sharing.
Site initiation and training. Study start-up includes site initiation visits and protocol-specific training for the research team. CEOs should ensure research coordinators have appropriate training support and that onboarding processes are efficient enough to meet sponsor start-up timeline expectations.
Feasibility and site selection strategy. Not all clinical trials are a good fit for every site. CEOs should build feasibility assessment capabilities that evaluate protocol requirements against the site’s patient population, investigator expertise, and operational capacity before committing to study activation.
Research Coordinator and Investigator Support
Clinical research depends heavily on the performance of research coordinators and investigators. CEOs must build the support systems that enable both groups to perform effectively:
Research coordinator training programs. Research coordinators manage the day-to-day conduct of clinical studies, including patient recruitment, protocol adherence, data collection, and adverse event reporting. CEOs should invest in formal training programs for coordinators, including GCP certification, protocol-specific training, and professional development pathways that support coordinator retention.
Protected research time for investigators. Physician-investigators need protected time from clinical duties to conduct research, mentor trainees, and write grants. CEOs should build compensation models that provide this protection and track whether protected time is actually available to investigators rather than consumed by clinical volume pressures.
Grant writing support. Federal grant applications are complex documents that require significant time to prepare. Research development offices that provide writing support, budget preparation assistance, and administrative coordination for grant submissions increase the organization’s grant submission volume and competitive success rates.
Clinical Trials Unit Operations
Healthcare organizations with significant clinical trial activity typically build a Clinical Trials Unit (CTU) or equivalent centralized infrastructure that provides operational support across multiple studies:
Centralized pharmacy services. Investigational drug storage, preparation, dispensing, and accountability require specialized pharmacy capabilities. CEOs should ensure their research pharmacy infrastructure meets FDA and sponsor requirements and is adequately staffed relative to the active trial portfolio.
Biospecimen collection and processing. Many clinical trials require blood, tissue, or other biospecimen collection with protocol-specific processing and storage requirements. CEOs should ensure the organization maintains adequate biospecimen processing capacity and cold storage infrastructure.
Data management systems. Clinical trial data must be collected, managed, and reported in compliance with ICH E6 Good Clinical Practice guidelines and sponsor requirements. CEOs should ensure data management systems are validated, compliant, and capable of supporting the organization’s trial portfolio volume.
Grant Management and Research Finance
Pre-Award Operations
The grant acquisition process requires operational capabilities that many healthcare organizations underinvest in. CEOs who build strong pre-award offices increase their organization’s federal funding competitiveness:
Sponsor opportunity identification. Research development staff who monitor federal funding opportunities and identify mechanisms aligned with the organization’s research priorities help investigators pursue the highest-opportunity grant programs.
Budget development and cost allocation. Federal grant budgets must accurately reflect the actual cost of research activities and comply with federal cost accounting standards. CEOs should ensure pre-award staff have the financial expertise to build compliant, complete grant budgets that recover the full cost of research.
Institutional review and approval. Most institutions require review and approval of grant applications before submission to confirm that institutional commitments are appropriate and that the budget has been correctly prepared. CEOs should ensure this review process is efficient enough that it supports submission deadlines without compressing investigator preparation time.
Post-Award Financial Management
Managing the financial compliance of active federal grants is a substantial operational responsibility. CEOs must ensure their organizations maintain the financial management systems required to spend federal funds in compliance with Uniform Guidance (2 CFR Part 200) and award-specific terms:
Sponsored projects accounting. A dedicated sponsored projects accounting function manages financial reporting, effort reporting, subcontract management, and closeout for federal awards. CEOs should ensure this function is adequately staffed relative to the active grant portfolio.
Effort reporting compliance. Federal regulations require personnel working on federal grants to certify that their effort allocations accurately reflect the time spent on each project. Effort reporting systems that are poorly designed or infrequently completed create compliance risk. CEOs should evaluate the adequacy of their effort reporting processes and invest in systems that make compliance accessible.
For perspective on how leading academic health systems build research infrastructure that sustains scientific productivity and financial compliance, Harvard Business Review’s research on health system leadership provides useful context on the governance and investment decisions that characterize high-performing research organizations.
Research Compliance and Regulatory Management
FDA Regulatory Compliance
Clinical trials involving investigational drugs or devices are subject to FDA oversight, including requirements for investigational new drug (IND) or investigational device exemption (IDE) applications, adverse event reporting, and data integrity. CEOs must ensure their organizations maintain the regulatory expertise to conduct FDA-regulated research in compliance with applicable requirements.
GCP training and auditing. FDA investigators can audit clinical trial records at any time. CEOs should ensure GCP training is current for all research personnel and that internal audit programs assess protocol adherence and data integrity on a regular basis.
Serious adverse event reporting. FDA and sponsor regulations require prompt reporting of serious adverse events in clinical trials. CEOs should ensure adverse event reporting processes are documented, that reporting timelines are met, and that safety monitoring data is reviewed at appropriate frequency.
For a broader operational framework applicable across healthcare business lines, the healthcare operations checklist provides a comprehensive reference for structuring executive oversight of research operations alongside clinical and administrative functions.
The healthcare community health programs article also provides relevant context on how health system CEOs connect research investment to community benefit outcomes and population health improvement.
Operational Metrics for Research CEOs
CEOs overseeing research operations should track:
- Study start-up cycle time: days from IRB approval to first patient enrollment, benchmarked against sponsor expectations
- Grant submission volume and success rate: the number of applications submitted and funded by agency and mechanism
- Research revenue by source: NIH, other federal, industry, and foundation funding as distinct revenue streams
- Protocol deviation rate: the number of reportable protocol deviations per 1,000 patient visits as a measure of protocol adherence
- Effort reporting compliance rate: the percentage of effort reports certified on schedule
- Active study portfolio size: the number of open studies and enrolled subjects as a measure of research capacity utilization
Conclusion
Research operations in healthcare require executive leadership that invests in the compliance infrastructure, financial management systems, and investigator support services needed to conduct high-quality, ethical research at scale. CEOs who build deliberate research operations capabilities create organizations that attract physician-scientists, compete successfully for federal and industry funding, and contribute to the evidence base that advances the quality of care for future patients.
The operational frameworks described in this guide, from IRB governance and study start-up operations to grant management and FDA compliance, provide the foundation for a research enterprise that fulfills its scientific mission while operating with the financial discipline and regulatory integrity that sustainable research programs require.
Related Reading
For further context, explore Healthcare CEO Business Operations Checklist and Healthcare CEO Business Operations for Accountable Care Organizations.