Director of Operations, US Market

Location: Hybrid, Remote andOn-site at ACR's U.S. clinical research sites

Travel: Occasional travel for training, conferences, or site oversight

Employment Type: Full-Time | Exempt

Salary: Competitive | Dependent on Experience

Assured Clinical Research (ACR) is a growing clinical research site network headquartered in the US, with active sites in the UK and Columbus, OH, and a planned expansion in both UK and US markets. ACR operates on a multi-modality model, with GP-embedded community sites and strategic partnerships, delivering Phase I-IV clinical trials across respiratory, metabolic, dermatologic, and other therapeutic areas.

Our Leadership team brings deep US clinical research experience
-our CEO has 20+ years of research experience with major networks - combined with the regulatory infrastructure of UK MHRA-regulated site operations. This dual-market positioning gives ACR a distinctive competitive advantage as sponsors seek globally diverse, high-quality investigational sites.

We are at an exciting inflection point: transitioning from site establishment to active business development, with the infrastructure, SOPs, and operational capability to support sponsors and CROs across multiple concurrent studies. The Director of Operations will be the driving force behind the day-to-day execution that makes ACR's U.S. growth possible.

The Director of Operations, U.S. holds the U.S. Operations seat on ACR's organizational Accountability Chart, reporting to the Integrator/Chief of Staff. This is a senior, hands-on operational role responsible for the day-to-day performance of ACR's U.S. clinical research sites, from staffing and study enrollment to quality, regulatory compliance, and site readiness.

You will build and lead site teams, own hiring and personnel decisions, and ensure every study is conducted to ICH-GCP and FDA standards. You will work closely with the Principal Investigator, Quality Assurance, and the Integrator/Chief of Staff to keep the U.S. sites audit-ready and positioned for growth as ACR's pipeline of studies expands.

• Own hiring decisions for site staff, including sourcing, interviewing, and final hire/no-hire determination.
• Own termination decisions for site staff, in coordination with HR to ensure a compliant process.
• Manage performance, staffing levels, and role assignments across the Coordinator and site support team.
• Drive participant recruitment, screening, and enrollment performance across active studies, in partnership with Business Development and Marketing.
• Monitor enrollment metrics against study targets and elevate risks to timeline proactively.

• Own site-wide compliance with ACR's U.S. SOP suite, ICH-GCP, and applicable FDA regulations.
• Lead internal audits, CAPA tracking, and protocol deviation management for the U.S. sites.

• Own site readiness for Sponsor audits, monitoring visits, and FDA inspections.
• Ensure Delegation of Authority Logs, training records, and essential documents/ISF are current and audit-ready.

• Oversee day-to-day site operations and resource allocation across concurrent studies.
• Oversee investigational product management, including receipt/return via Sponsor depot arrangements and accountability logging.

• Maintain compliance with 21 CFR Parts 11/50/54/56/312 and HIPAA across site operations.

• Lead the U.S. site team, setting clear direction and expectations for Coordinators and site support staff.
• Manage day-to-day performance and workflow across the team.
• Hold direct reports accountable to defined goals, quality standards, and deadlines, addressing performance gaps directly and promptly.

• 5+ years of clinical research site management or clinical operations experience, including direct hiring and personnel management authority.
• Strong working knowledge of ICH-GCP and FDA regulations (21 CFR Parts 11, 50, 54, 56, 312) and HIPAA.
• Demonstrated experience managing site staff, study enrollment performance, and Sponsor/CRO relationships.
• Experience supporting or leading through Sponsor audits…