Site Director – Phase I Clinical Research

A well-established clinical research site organisation conducting Phase I-IV clinical trials is seeking a Site Director to lead a large, high-volume Phase I inpatient facility in Miami, FL. Onsite role, with relocation support available.

About the role

The Site Director is responsible for the overall management of the clinical research business, overseeing coordination, organisation and efficient implementation of clinical trials, operations and regulatory compliance. Works closely with senior leadership, Principal Investigators, Recruitment and Clinical Research Coordinators to ensure study-related procedures are completed properly from a clinical and regulatory perspective, guided by GCP, ICH, HIPAA and company SOPs.

Responsibilities

• Supervise and mentor direct reports, overseeing HR functions including performance evaluations, recruitment, onboarding, conflict resolution and staff scheduling
• Develop and implement business plans to achieve site strategic and operational goals
• Maintain SOPs, working guidelines and quality management plans across clinical trial delivery
• Manage and motivate staff to meet enrollment goals
• Contribute to business development and feasibility reviews, including Go/No-Go decisions
• Evaluate study protocols for enrollment potential and site capability
• Coordinate site visits and sponsor communications
• Oversee subject recruitment planning
• Oversee preparation and submission of regulatory materials
• Ensure studies comply with GCP and ICH guidelines
• Design and oversee the site's Quality Assurance programme
• Approve hires and contractors in consultation with HR and Operations leadership
• Coordinate with centralised support functions (Finance, Contracting, Business Development, Quality Assurance)

Requirements

• B.A. or B.S. required; advanced degree preferred
• Minimum 3 years' experience managing clinical trials
• Proven experience running a large, high-volume inpatient Phase I clinic
• Strong understanding of GCP, HIPAA and ICH guidelines
• Demonstrated experience hiring, training, onboarding and managing clinical staff
• Experience managing multiple departments (nursing, CRCs, regulatory, recruitment, lab)
• Strong budget and operational awareness
• Excellent communication and interpersonal skills
• Ability to travel overnight as needed
• Proficiency in Word, Excel, PowerPoint and clinical trial management systems
• Bilingual in English and Spanish
• Background in a commercial Phase I unit rather than academic or university research