Regional Site Manager

Proclinical; Bronx (ID); Hybrid; USD 80,000 - 120,000; Full time

Job summary

Proclinical is seeking a Regional Site Manager to oversee clinical research operations across multiple sites in the Bronx, NY and surrounding region. This permanent, full-time role blends remote work with substantial travel to sites, approximately 50% monthly, to ensure study startup through closeout runs smoothly.

You will lead Clinical Research Coordinators, manage startup activities, budgets, IRB submissions, and regulatory documentation, while maintaining strict GCP and FDA standards.

Qualifications

• Bachelor's degree in health sciences, clinical research, or related field.
• Strong knowledge of GCP and FDA regulations.
• Experience in site management and supervising CRCs.
• Familiarity with study startup processes, budgets, IRB submissions, and regulatory docs.
• Proven leadership and ability to manage multiple studies and sites.

Responsibilities

• Supervise and support Clinical Research Coordinators across sites with performance guidance.
• Recruit, interview, hire, and train CRCs on protocols and GCP.
• Manage study startup activities, including budgets, agreements, and site activation.
• Track training on protocol updates and amendments.
• Provide updates on progress, enrollment, and data quality.
• Collaborate with study teams to resolve issues and meet timelines.
• Review study budgets to ensure cost-effective implementation.

Skills

GCP knowledge

FDA regulations

Site management

Leadership

Communication

Travel readiness

Education

Bachelor's degree in health sciences

Advanced degree preferred

Tools

CTMS

IRB submission systems

Budgeting tools

Job description

Regional Site Manager - Permanent - Bronx, NY

Ready to lead high-performing clinical research sites and drive operational excellence across a growing region?

Proclinical is seeking a Regional Site Manager to oversee clinical research operations across multiple sites within an assigned region. The position requires a mix of remote work and travel to sites, with approximately 50% travel each month.

Primary Responsibilities:

The successful candidate will be involved in ensuring operational excellence, regulatory compliance, and high-quality research practices from study startup through closeout.

Skills & 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.
• Bonus: Experience working with research-naive physicians and sites.

The Regional Site Manager's responsibilities will be:

• 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.

Compensation:

• $80 000 - $120 000/Annum