Director of Research Operations

Cardiovascular Associates of America•,

About The Position

The Director of Research Operations leads day-to-day operational execution of a growing, multi-site clinical trials portfolio. Reporting to the Vice President of Research, the Director translates research strategy and growth objectives into consistent, measurable operational execution across the clinical trials enterprise. The role oversees the operational foundation of clinical trial delivery, ensuring studies progress efficiently from award through startup, activation, recruitment, enrollment, conduct, and closeout; sites have the resources and support to perform; operational teams coordinate across functions; and leadership has visibility into performance, risks, and resource needs. Functional areas include site operations, study startup and activation, regulatory operations, recruitment and enrollment, trial delivery and project management, research systems and training, and operational data and performance management. This is an execution-focused leadership position. The Director makes day-to-day operational decisions within established strategy, policies, budgets, and quality standards, and partners with executive research leadership on significant financial, strategic, staffing, portfolio, quality, compliance, or service-line matters. Success means creating the structure, leadership, operating discipline, and accountability that allow clinical trial operations to function predictably as the research network grows, without continuous executive intervention.

Requirements

Extensive clinical research experience with progressive responsibility in research operations and leadership.
Demonstrated experience overseeing clinical trial execution across multiple studies, sites, or research programs.
Strong operational knowledge of study startup, regulatory processes, recruitment and enrollment, trial conduct, and study closeout.
Experience leading teams and coordinating work across multiple functional areas.
Demonstrated ability to build operational processes and establish accountability in a growing or changing organization.
Strong understanding of Good Clinical Practice (GCP) and sponsor-supported clinical trial operations.
Demonstrated ability to identify complex operational problems, develop practical solutions, and drive implementation through completion.
Strong project-management, organizational, and prioritization skills.
Ability to interpret operational data and use it to drive decisions and performance improvement.
Strong leadership and communication skills and ability to work effectively with investigators, research staff, clinical practices, sponsors, CROs, and executive leadership.

Nice To Haves

Experience within a multi-site clinical research organization, healthcare network, site network, or similarly distributed research environment.
Experience building or scaling clinical research operations.
Experience supporting cardiovascular or other complex therapeutic-area clinical trials.
Experience implementing or optimizing centralized research services.
Experience with clinical trial management systems, electronic source, electronic regulatory systems, recruitment technologies, and other research platforms.
Experience developing operational dashboards, KPIs, and performance-management processes.

Responsibilities

Own operational execution of the clinical trials portfolio from study award through closeout.
Translate organizational priorities into operational plans, responsibilities, timelines, and performance expectations.
Create consistent operating practices across centralized research functions and participating research sites.
Monitor portfolio health, including startup progress, enrollment, milestones, staffing, workload, risks, and barriers; ensure issues are assigned, escalated as needed, and resolved.
Ensure sites have the infrastructure, processes, staffing support, training, and centralized resources required to conduct trials successfully.
Set and evaluate site performance expectations, operational readiness, workload, enrollment, study execution, and barriers; partner with site and practice leadership to address challenges and maintain accountability.
Balance network-wide standardization with the needs of individual practices, investigators, and studies, and simplify processes where possible.
Drive study progress from award through site activation by coordinating regulatory work, site readiness, systems setup, training, investigator preparation, and operational planning.
Set and monitor measurable startup expectations and address recurring causes of activation delays.
Strengthen processes for identifying, screening, and enrolling appropriate participants; coordinate centralized recruitment resources with site and clinical-practice workflows.
Integrate research into routine patient care, monitor recruitment funnels and enrollment performance, and ensure underperforming studies have actionable recruitment plans and follow-through.
Establish consistent project-management standards, operational plans, timelines, meeting structures, deliverables, action tracking, escalation pathways, and communications across active studies.
Clarify ownership of study activities and track commitments to sponsors, investigators, sites, and internal stakeholders through completion; identify studies needing intervention before milestones are missed.
Integrate regulatory activities into startup and ongoing study operations, including submissions, essential-document management, investigator documentation, amendments, continuing reviews, and closeout.
Make regulatory workload and timelines visible in study planning and partner with quality and compliance leadership to translate findings and corrective actions into sustainable practices.
Ensure research technology supports trial execution; drive adoption and use of clinical trial management, electronic source, electronic regulatory, recruitment, and other research platforms.
Identify workflow and technology barriers and lead improvements; provide onboarding, systems training, role-based training, and ongoing operational education.
Identify appropriate opportunities to use technology, automation, data, and artificial intelligence to improve research operations.
Develop and maintain operational metrics for startup, enrollment, trial and site performance, staffing, workload, and delivery; use data to identify trends, anticipate needs, and guide resource allocation.
Establish operating reviews that identify decisions, owners, actions, and deadlines, and provide executive research leadership with concise visibility into performance, risks, resource needs, and issues requiring intervention.
Build and develop a collaborative research operations organization with clear responsibilities, accountability, integrated functional teams, and a culture of ownership, responsiveness, transparency, and continuous improvement.
Develop team members and leaders, assess staffing and workload as the portfolio grows, and recommend resource changes based on operational demand.
Determine operational resource deployment, workflow structure, issue resolution, and when performance concerns require intervention or escalation; bring assessments, recommended solutions, and execution plans when escalating matters requiring executive authority.