Director, Research Site Operations

CTI Clinical Trial and Consulting Services•Norwood, OH

1d•Hybrid

About The Position

CTI Clinical Trial and Consulting Services is seeking a Director, Research Site Operations to lead overall site operations, including daily clinical research site execution, participant flow, staffing, scheduling, study readiness, documentation quality, issue escalation, and operational continuity. This role involves translating site and business objectives into clear operating plans, priorities, metrics, governance routines, and accountability mechanisms. The Director will partner with leadership to execute the growth strategy for the research site, overseeing all aspects of study conduct from planning and start-up to close-out activities. Ensuring compliance with protocol requirements, ICH/GCP, and regulatory standards is paramount. This position serves as a senior escalation point for critical issues affecting study delivery, participant safety, data integrity, and inspection readiness. The role requires providing leadership and direction to site managers and clinical staff, building and coaching a high-performing team, and partnering with medical and investigative staff to support appropriate medical oversight and participant-centered care. The Director will also oversee study readiness activities, lead protocol feasibility assessments, establish and monitor operational performance metrics, and collaborate with Quality Assurance to maintain audit-ready processes. Cross-functional collaboration with Finance, Contracts, Project Management, and Business Development is essential for supporting budgets, resource planning, and profitable delivery of services. The role involves leading communication with internal stakeholders and sponsors, promoting a culture of participant safety and operational excellence, and maintaining readiness for urgent operational needs and emergencies.

Requirements

Ability to translate site strategy into scalable operating plans, capacity models, governance routines, and measurable outcomes.
Strong understanding of trial execution, including inpatient or high-intensity visit models, participant safety workflows, recruitment, eligibility, source documentation, and study-specific site setup.
Practical knowledge of ICH/GCP, informed consent, HIPAA/privacy expectations, trial documentation, protocol compliance, deviation management, CAPA support, and inspection readiness.
Proven ability to lead managers and multidisciplinary teams, establish accountability, coach for performance, build succession depth, and foster a collaborative culture.
Ability to communicate clearly with sponsors, investigators, senior leaders, auditors, and cross-functional teams on risks, decisions, timelines, and recovery actions.
Ability to understand budgets, resource utilization, staffing models, revenue and profitability drivers, change impacts, and growth opportunities research site.
Ability to interpret performance dashboards, enrollment trends, quality metrics, staffing data, and sponsor feedback to make timely, evidence-based decisions.
Ability to modernize workflows, strengthen SOP adherence, improve technology adoption, and lead teams through evolving trial designs and sponsor expectations.
Ability to anticipate operational, compliance, participant safety, staffing, facility, recruitment, and sponsor delivery risks and establish practical mitigation plans.
Ability to align work across Clinical Operations, Quality Assurance, Medical/PI leadership, Finance, Legal, Business Development, vendors, and clients.
Bachelor’s degree in life sciences, nursing, healthcare administration, clinical research, business, or a related field, or equivalent combination of education and directly relevant experience.
10+ years of progressive clinical research, clinical operations, research site operations, healthcare operations, or CRO/sponsor experience.
5+ years of people leadership, site leadership, department leadership, or equivalent matrix leadership experience in a clinical research or healthcare setting.
Demonstrated knowledge of ICH/GCP, protocol execution, informed consent, participant safety escalation, trial documentation, quality oversight, and audit/inspection readiness expectations.
Experience managing multidisciplinary clinical research teams and coordinating work across investigators, clinical staff, recruitment, regulatory, quality, operations, finance, and sponsor stakeholders.
Experience developing or supporting operational metrics, staffing plans, study readiness processes, recruitment/enrollment plans, quality improvement actions, or financial/resource plans.
Proficiency with Microsoft Office applications and standard clinical research systems such as CTMS, eSource/eRegulatory tools, EDC, recruitment systems, dashboards, or related technologies.

Responsibilities

Lead overall site operations, including daily clinical research site execution, participant flow, staffing, scheduling, study readiness, documentation quality, issue escalation, and operational continuity.
Translate site and business objectives into clear operating plans, priorities, metrics, governance routines, and accountability mechanisms.
Partner with VP, Research Site Services and Business Development to execute the growth strategy for the research site, including portfolio mix, operational capacity, service capabilities, and sponsor-facing value proposition.
Oversee planning, start-up, conduct, enrollment, subject visit execution, data/documentation readiness, and close-out activities for studies conducted at the unit.
Ensure site operations are conducted in accordance with protocol requirements, ICH/GCP, applicable regulatory requirements, informed consent expectations, participant privacy obligations, CTI SOPs, sponsor requirements, and trial-specific procedures.
Serve as a senior escalation point for operational, participant safety, staffing, quality, sponsor, system, vendor, or facility issues that may affect study delivery, participant experience, data integrity, or inspection readiness.
Provide leadership and direction to site managers, clinical research coordinators, laboratory, nursing or clinical staff, and other site contributors, directly or through subordinate leaders.
Build, coach, and retain a high-performing site leadership team by setting clear expectations, reinforcing accountability, developing talent, succession planning, and addressing performance issues promptly and fairly.
Partner with Medical Directors, Principal Investigators, Sub-Investigators, and clinical staff to support appropriate medical oversight, protocol feasibility, subject eligibility, study conduct, safety escalation, and participant-centered care.
Oversee study readiness activities, including source templates, delegation logs, training documentation, workflow boards, laboratory and vendor setup, equipment readiness, recruitment plans, staffing schedules, and site initiation preparation.
Lead or support protocol feasibility assessments, operational readiness reviews, enrollment strategy, recruitment strategy, budget input, sponsor qualification visits, pre-study visits, bid defense preparation, and business development activities site opportunities.
Establish and monitor operational performance metrics, including enrollment, screen failure trends, visit execution, protocol deviation patterns, data entry timeliness, query resolution, participant retention, staff utilization, quality findings, and financial or budget performance.
Use performance data, quality signals, sponsor feedback, and lessons learned to identify operational risks, improve processes, strengthen predictability, and drive continuous improvement across the clinical research center.
Partner with Quality Assurance to maintain audit-ready processes, support sponsor audits and regulatory inspections, manage CAPA-related activities, ensure SOP currency, and embed quality-by-design and risk-based thinking into site operations.
Collaborate with Finance, Contracts, Project Management, Business Development, and operational leaders to support budgets, resource planning, change order awareness, contractual commitments, and profitable delivery of site-based research services.
Lead cross-functional communication with internal stakeholders and sponsor representatives, including status updates, operational risks, recovery plans, issue resolution, and decision recommendations.
Promote a culture of participant safety, ethical conduct, inclusion, inspection readiness, sponsor service, operational excellence, and continuous improvement.
Maintain readiness for urgent operational needs, after-hours escalations, site emergencies, facility alerts, temperature excursions, or other time-sensitive issues that require senior site leadership involvement.
Perform other duties, responsibilities, and special projects as assigned based on business needs.