Director of Research Operations
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Job Description
Director leading day-to-day operations for Cardiovascular Associates of America’s multi-site clinical trials network. Building scalable processes, accountability, and performance visibility across sites and research teams.
Responsibilities:
- Lead day-to-day 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 startup progress, enrollment performance, operational milestones, staffing, workload, and risks
- Ensure issues are assigned, escalated when necessary, and followed through to resolution
- Ensure sites have the infrastructure, processes, staffing support, training, and centralized resources needed for successful trial execution
- Drive study startup and site activation, including regulatory activities, systems setup, training, investigator preparation, and operational planning
- Strengthen participant recruitment, screening, and enrollment processes
- Establish project-management standards, operational plans, timelines, deliverables, action-item tracking, escalation pathways, and communications
- Integrate regulatory operations into startup and ongoing trial delivery
- Optimize clinical trial management, electronic source, electronic regulatory, recruitment, and other research platforms
- Ensure onboarding, systems training, role-based training, and ongoing operational education
- Develop operational metrics, dashboards, operating reviews, and accountability processes
- Provide executive research leadership with visibility into performance, risks, resource requirements, and issues requiring intervention
- Build and develop a high-performing research operations team and evaluate staffing needs as the portfolio grows
- Make operational decisions within established strategy, policies, budgets, and quality standards
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 with the ability to work effectively with investigators, research staff, clinical practices, sponsors, CROs, and executive leadership
- Preferred: Experience within a multi-site clinical research organization, healthcare network, site network, or similarly distributed research environment
- Preferred: Experience building or scaling clinical research operations
- Preferred: Experience supporting cardiovascular or other complex therapeutic-area clinical trials
- Preferred: Experience implementing or optimizing centralized research services
- Preferred: Experience with clinical trial management systems, electronic source, electronic regulatory systems, recruitment technologies, and other research platforms
- Preferred: Experience developing operational dashboards, KPIs, and performance-management processes
Benefits:
- Remote work arrangement
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