Lead High-Performing Clinical Research Sites
Drive operational excellence across a growing region by overseeing clinical research operations at multiple sites. This role combines remote work with regional travel, requiring approximately 50% travel each month to ensure high-quality research practices from study startup through closeout.
Primary Responsibilities
- Supervise and support Clinical Research Coordinators (CRCs) across designated sites, including performance evaluations and guidance.
- Recruit, interview, hire, and train CRCs on protocols, Good Clinical Practice (GCP), and regulatory requirements.
- Manage study startup activities, including clinical trial agreements, budget preparation, IRB submissions, and site activation.
- Track training completion for protocol updates and amendments.
- Provide regular updates on study progress, enrollment, and data quality at each site.
- Collaborate with study teams to resolve issues and ensure timelines are met.
- Review and analyze study budgets and procedure costs to ensure cost-effective implementation.
- Build relationships with local hospitals, laboratories, and vendors, coordinating operational readiness during startup.
- Offer structured feedback to product and technology teams to refine platform features and workflows.
Skills and Requirements
- Bachelor's degree in health sciences, clinical research, or a related field; advanced degree preferred.
- Strong knowledge of GCP, FDA regulations, and clinical research operations.
- Experience in site management roles, including hiring and supervising CRCs.
- Familiarity with study startup processes, contracts, budgets, IRB submissions, and regulatory documentation.
- Proven leadership and organizational skills to manage multiple studies, sites, and timelines.
- Effective communication skills for collaboration with investigators, site staff, sponsors, CROs, and internal teams.
- Ability to travel regionally as required.
- Experience working with research-naive physicians and sites is a bonus.
Compensation
$80,000 - $120,000 per annum