Clinical Research Coordinator I: Start-Up & Compliance Expert

University of Central Florida; Orlando (FL); On-site; USD 56,000 - 69,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Flexible Spending

Employee Assistance Program

Paid time off

Retirement savings

Employee discounts

Education assistance

Job summary

The University of Central Florida College of Medicine is seeking an experienced clinical research professional to provide expert support to the Manager-Clinical Trials in business development, start-up, quality assurance, study operations, and study closure for clinical research projects and clinical trials.

Responsibilities include coordinating with sponsors, monitors, auditors, and investigators to ensure activation, regulatory compliance, and efficient study conduct, from feasibility through

Qualifications

• Bachelor's orMaster's degree with 2+ years of relevant experience.
• Experience with regulatory submissions and IRB/FDA applications.
• Experience with clinical trials and data management.
• Ability to work with sponsors, monitors, and auditors.
• U.S. work authorization; visa sponsorship not available.

Responsibilities

• Assist with business development by building rapport with industry sponsors and funders.
• Navigate start-up and close-out processes for clinical research projects and trials; prepare regulatory submissions.
• Assist with clinical research budgets, procurement, and study accounts.
• Coordinate study activities: consent sessions, data collection, scheduling site visits, data entry into EMR/CRFs.
• Ensure compliance with protocols and Good Clinical Practice; prepare for audits and monitor visits.
• Serve as a resource for stakeholders and community regarding clinical research.

Skills

Stakeholder management

Regulatory knowledge

Clinical research

Budgeting

Communication

Data management

Education

Bachelor's or Master's degree

Tools

IRB submission systems

ClinicalTrials.gov

Job description

The University of Central Florida College of Medicine is seeking an experienced clinical research professional to provide expert support to the Manager-Clinical Trials in business development, start-up, quality assurance, study operations, and study closure for clinical research projects and clinical trials.

Responsibilities include coordinating with sponsors, monitors, auditors, and investigators to ensure activation, regulatory compliance, and efficient study conduct, from feasibility through