Clinical Research Regional Manager, Rheumatology
Overview
You will own daily operations and staff success across multiple rheumatology research sites. This role manages a team of coordinators and assistants, ensuring compliance, productivity, and enrollment goals. You'll drive training, mentorship, and quality assurance while collaborating with physicians and sponsors. 5+ years experience and ICH-GCP expertise set you up for impact at the largest private rheumatology practice in the US.
What You'll Do10
- 1Travel daily to research sites, support coordinators, and resolve operational issues.
- 2Manage, supervise, and evaluate research coordinators and assistants, including hiring, reviews, and corrective actions.
- 3Train and mentor new staff, assigning tasks and studies to balance workloads.
- 4Use CTMS weekly to track productivity and monitor EDC reports to meet data and query goals.
- 5Meet with employees monthly to review metrics and lead weekly team huddles.
- 6Implement Clinical Trial Agreements and budgets, ensuring fiscal operations.
- 7Ensure compliance with ICH-GCP, FDA 21 CFR, IRB Guidelines, and state/federal laws.
- 8Conduct Pre-Study Visits and Site Initiation Visits for new trials.
- 9Serve as escalation point for trials, communicating with physicians, vendors, sponsors, and CROs.
- 10Facilitate site recruitment and enrollment, ensuring medical equipment and resources are ready.
Requirements7
- 1Bachelor's Degree or equivalent, with 2+ years as a clinical research coordinator.
- 2Subject matter expert in clinical research and relevant medical indications.
- 3Knowledge of ICH-GCP and FDA regulations.
- 4Strong leadership and organizational skills, with excellent communication.
- 5Willingness to travel daily to regional offices.
- 6Management experience or formal training preferred, not required.
- 7Clinical Research Certification (CRCC/CCRP) preferred, not required.
Salary Insight
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