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Director, Research Site Operations

What you'll do:


* 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-Inestigators, 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...




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