Senior Clinical Research Lead, Trials & Operations

University of Florida; Jacksonville (FL); On-site; USD 82,000 - 95,000; Full time

Job summary

University of Florida in Jacksonville is seeking a Clinical Research Manager who will provide leadership for the Clinical Research Office, oversee planning and execution of clinical studies, and ensure compliance with FDA regulations while mentoring investigators in the life cycle of clinical trials and sponsor interactions.

The role supports growth of CRO capabilities, expansion of decentralized trials, collaboration with PIs and sponsors, and development of SOPs and budgets to improve study

Qualifications

• Master's degree in appropriate area of specialization; or a bachelor's degree in appropriate areas of specialization and two years of experience.
• Experience leading interdisciplinary clinical research teams and coordinating with sponsors and stakeholders.

Responsibilities

• Oversee study planning, protocol development, and execution.
• Ensure FDA regulatory compliance and IRB alignment across trials.
• Coach investigators and staff on trial lifecycles and sponsor interactions.
• Develop and implement SOPs, training, and quality improvement initiatives.
• Monitor budgeting, financial management, and study payments.

Skills

Team leadership

FDA regulations

ICH-GCP guidelines

IRB processes

Clinical research operations

Budgeting

Education

Master's degree or higher in relevant field

Bachelor's degree + 2 years experience

Tools

CRO operations

Job description

University of Florida in Jacksonville is seeking a Clinical Research Manager who will provide leadership for the Clinical Research Office, oversee planning and execution of clinical studies, and ensure compliance with FDA regulations while mentoring investigators in the life cycle of clinical trials and sponsor interactions.

The role supports growth of CRO capabilities, expansion of decentralized trials, collaboration with PIs and sponsors, and development of SOPs and budgets to improve study