Site Lead

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

Lead Clinical Research Operations and Drive Study Success

Excellent opportunity for experienced clinical research leaders with expertise in Phase I and early-phase clinical trials

Are you passionate about clinical operations, site leadership, and advancing innovative therapies? We're looking for a Site Director to lead clinical research operations at one of ERG's premier research sites, overseeing study execution, business performance, quality, regulatory compliance, and team leadership.

If you thrive in a fast-paced clinical research environment and enjoy leading high-performing teams while driving operational excellence, this could be your next opportunity.

What You'll Do

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

What We're Looking For

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

Knowledge and experience with:

• Clinical Research Operations
• Clinical Trial Management
• Phase I Clinical Trials
• Patient Recruitment and Retention
• 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

Base Salary: $175,000 - $200,000 annually, depending on experience and qualifications.

Additional compensation and benefits package available

Relocation Assistance Available

Please Note

On-site in Miami, FL

Full-time leadership position overseeing clinical research operations

Phase I and early-phase clinical research experience required

Overnight business travel may be required

Relocation assistance is available for qualified candidates

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