Site Director: Phase I Trials & Operational Excellence

BioTalent; Miami (FL); On-site; USD 175,000 - 200,000; Full time

Benefits offered by this job

Relocation assistance available

On-site in Miami, FL

Job summary

BioTalent in Miami, FL seeks a Site Director to lead clinical research operations at a premier site, overseeing study execution, business performance, quality, regulatory compliance and team leadership.

This role requires Phase I and early-phase trial experience, English and Spanish bilingualism, and a Bachelor's in a scientific field; on-site work with relocation support and a competitive base salary.

Qualifications

• Bachelor's degree in a scientific or healthcare-related field.
• 7-10 years of experience in clinical operations, including 5+ years in a senior leadership role.
• Phase I or early-phase clinical research experience.
• Bilingual in English and Spanish.

Responsibilities

• Lead the overall operations, profitability, and strategic execution of a clinical research site.
• Manage, mentor, and develop site staff while overseeing recruitment, onboarding, training, and performance management.
• Drive study enrollment, patient recruitment, retention efforts, and site performance metrics.
• Oversee clinical trial operations to ensure studies are conducted in compliance with protocols, GCP, ICH, HIPAA, and regulatory requirements.
• Partner with sponsors, investigators, business development teams, and operational leadership to evaluate and execute new research opportunities.
• Manage site quality assurance programs, regulatory submissions, IRB interactions, and staff training initiatives.
• Coordinate cross-functional teams and centralized support services to ensure successful study delivery.
• Serve as the primary leadership contact for sponsors, internal stakeholders, and executive management

Skills

Clinical Research Operations

Clinical Trial Management

Phase I Clinical Trials

GCP Compliance

ICH Guidelines

HIPAA Requirements

Regulatory Affairs

IRB Processes

Quality Assurance

Medical Terminology

Business Development Support

Site Operations

Study Start-Up and Execution

Microsoft Office Suite

Education

Bachelor's degree in a scientific or healthcare-related field

Tools

Microsoft Office Suite

Job description

BioTalent in Miami, FL seeks a Site Director to lead clinical research operations at a premier site, overseeing study execution, business performance, quality, regulatory compliance and team leadership.

This role requires Phase I and early-phase trial experience, English and Spanish bilingualism, and a Bachelor's in a scientific field; on-site work with relocation support and a competitive base salary.