Director of Clinical Trials Operations & Delivery

Cardiovascular Associates of America - CVAUSA; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Cardiovascular Associates of America - CVAUSA is seeking an experienced Director of Research Operations to lead the day-to-day execution of a growing, multi-site clinical trials portfolio. You will translate strategy into measurable operations across trial delivery, startup, recruitment, and performance management.

The role requires building scalable processes, leading cross-functional teams, and delivering actionable insights to executives and sponsors.

Qualifications

• Extensive clinical research experience with leadership responsibility.
• Oversee execution across multiple studies, sites, or programs.
• Strong knowledge of study startup, regulatory processes, recruitment/enrollment, conduct, and closeout.
• Experience leading cross-functional teams.
• Ability to build operational processes and establish accountability in a growing operation.

Responsibilities

• Own the operational execution of the clinical trials portfolio from award through closeout.
• Translate organizational priorities into clear operational plans, responsibilities, timelines, and performance expectations.
• Create consistent operating practices across centralized research functions and participating research sites.
• Maintain visibility into the health of the clinical trial portfolio, including startup progress, enrollment performance, operational milestones, staffing and workload, and significant risks or barriers.
• Ensure issues are identified early, assigned to the appropriate owner, escalated when necessary, and followed through to resolution.
• Establish clear expectations for site performance and routinely evaluate operational readiness, workload, enrollment performance, study execution, and barriers to success.
• Partner with site and practice leadership to address operational challenges while maintaining accountability for performance.
• Balance network-wide standardization with the practical needs of individual practices, investigators, and studies.
• Identify opportunities to simplify processes, reduce duplication, and improve the experience of conducting research within participating practices.
• Drive efficient movement of studies from award through site activation.
• Ensure coordination of regulatory activities, site readiness, systems setup, training, investigator preparation, operational planning, and other startup requirements.
• Establish measurable startup expectations and monitor studies against those expectations.
• Identify recurring causes of activation delays and implement process improvements to address them.
• Ensure effective operational processes for identifying, screening, and enrolling appropriate research participants.
• Coordinate centralized recruitment resources with site-based recruitment and clinical-practice workflows.
• Strengthen integration of clinical research into routine patient care so that investigators and clinical teams can effectively identify potential participants.
• Establish visibility into recruitment funnels and enrollment performance and ensure underperforming studies have actionable recruitment plans.
• Drive follow-through and accountability for enrollment initiatives.
• Create consistent project-management standards across active studies.
• Ensure studies have appropriate operational plans, timelines, meeting structures, deliverables, action-item tracking, escalation pathways, and communication processes.
• Establish clear ownership of study activities and ensure commitments to sponsors, investigators, sites, and internal stakeholders are tracked through completion.
• Develop processes that allow leadership to identify studies requiring intervention before significant milestones are missed.
• Ensure regulatory activities are effectively integrated into startup and ongoing study operations.
• Maintain efficient processes for submissions, essential-document management, investigator documentation, amendments, continuing reviews, and closeout activities.
• Ensure regulatory workload and timelines are visible within overall study planning.
• Partner with quality and compliance leadership to address operational findings and ensure corrective actions are translated into sustainable operational practices.
• Ensure research technology supports efficient trial execution across the network.
• Drive effective adoption and utilization of clinical trial management, electronic source, electronic regulatory, recruitment, and other research platforms.
• Identify workflow or technology barriers that create unnecessary administrative burden and lead efforts to improve them.
• Ensure research staff receive onboarding, systems training, role-based training, and ongoing operational education.
• Identify opportunities to appropriately use technology, automation, data, and AI to improve research operations.
• Develop and maintain meaningful operational metrics related to study startup, enrollment, trial performance, site performance, staffing, workload, and delivery.
• Use data to identify trends, anticipate operational needs, and guide resource allocation.
• Establish regular operating reviews that move beyond reporting to decisions, owners, actions, and deadlines.
• Provide executive leadership with concise visibility into performance, risks, resource needs, and issues.

Skills

Clinical research leadership

Multi-site oversight

Study startup & regulatory

Recruitment & enrollment

Cross-functional leadership

Job description

Cardiovascular Associates of America - CVAUSA is seeking an experienced Director of Research Operations to lead the day-to-day execution of a growing, multi-site clinical trials portfolio. You will translate strategy into measurable operations across trial delivery, startup, recruitment, and performance management.

The role requires building scalable processes, leading cross-functional teams, and delivering actionable insights to executives and sponsors.