Lead Clinical Research Coordinator, Urology Trials

GI Alliance; Germantown (TN); On-site; USD 65,000 - 90,000; Full time

Job summary

GI Alliance seeks an Experienced Research Coordinator to build and lead a growing research department within a large private practice urology group. You will work closely with PI and Sub-Is, manage multiple studies, and oversee trial operations with support staff and budget allocated.

This role emphasizes regulatory compliance, patient safety and data integrity. The candidate will mentor junior coordinators, ensure HIPAA compliance, and coordinate with IT and data teams to advance the research

Qualifications

• Experience coordinating multiple clinical studies simultaneously.
• Strong understanding of FDA, GCP, ICH regulations.
• Urology clinical experience preferred.
• ACRP certification or equivalent preferred.
• Proficiency with EMR and practice management systems.
• Excellent communication with cross-functional teams.

Responsibilities

• Lead recruitment of studies, protocol conduction, and sponsor communication.
• Maintain knowledge of FDA, GCP, ICH, and state regulations; ensure compliance and consent.
• Conduct study visits: screen, consent, collect history, perform procedures (EKG, blood draw, vitals).
• Coordinate with IRB, PIs, Sub-Is; participate in meetings and calls.
• Ensure HIPAA-compliant communications and data handling.
• Collaborate with Regional Manager and Research Director on daily operations and procedures.
• Manage data in EMR and CTMS; ensure data quality and source documentation.
• Assist with site visits, SIVs, monitoring, and trial close-out steps.

Skills

Clinical coordination

Regulatory knowledge

Communication skills

Team leadership

EMR proficiency

CTMS familiarity

Education

Bachelor's degree in health field

ACRP certification preferred

Tools

EMR

CTMS

Practice management systems

Microsoft Office

Job description

GI Alliance seeks an Experienced Research Coordinator to build and lead a growing research department within a large private practice urology group. You will work closely with PI and Sub-Is, manage multiple studies, and oversee trial operations with support staff and budget allocated.

This role emphasizes regulatory compliance, patient safety and data integrity. The candidate will mentor junior coordinators, ensure HIPAA compliance, and coordinate with IT and data teams to advance the research