Regional Clinical Research Leader - Multi-Site Trials

GI Alliance; Alexandria (VA); On-site; USD 110,000 - 150,000; Full time

Job summary

GI Alliance is seeking a Regional Clinical Research Manager to coordinate trials across 3-4 sites within a region, reporting to the VP of Operations and Director of Research Strategy and Operations. You will supervise clinical staff to ensure compliant, high-quality trial conduct.

The role requires 5+ years of trial experience, with preferred focus on urology trials, and a strong grasp of GCP, FDA guidelines, and CTMS/EDC systems. Occasional travel between sites is expected.

Qualifications

• ≥ 5 yrs experience with conducting clinical trials.
• Urology based clinical research experience highly preferred.
• Held previous leadership roles within an organization.
• Bachelor’s degree in a health or science field preferred.
• Experience with FDA, GCP, ICH and regulatory guidelines.

Responsibilities

• Lead and manage research departments across locations and markets.
• Oversee CRCs: training, staffing, and performance reviews.
• Assist with patient recruitment, site initiation, monitoring, audits.
• Maintain regulatory documentation and ensure compliance.
• Collaborate with IRB, sponsors, PIs and clinics.
• Prepare for FDA inspections and ensure study conduct.

Skills

Phone systems

Communication

Study protocol budgets

Medical terminology

Time management

Education

Bachelor’s degree in health or science

Tools

Microsoft Office

EMR

Practice Management

EDC

CTMS

Job description

GI Alliance is seeking a Regional Clinical Research Manager to coordinate trials across 3-4 sites within a region, reporting to the VP of Operations and Director of Research Strategy and Operations. You will supervise clinical staff to ensure compliant, high-quality trial conduct.

The role requires 5+ years of trial experience, with preferred focus on urology trials, and a strong grasp of GCP, FDA guidelines, and CTMS/EDC systems. Occasional travel between sites is expected.