Director Mcvi Research & Outcomes, Mcvi Research, FT, 8A-4:30P

Provides strategic, operational, financial, and regulatory oversight for all cardiovascular clinical trial activities across the health system's inpatient hospitals and outpatient ambulatory clinics, including standardization of clinical trial workflows, patient recruitment strategies, and data collection protocols. Manages clinical research coordinators, interfaces directly with practicing clinicians, and ensures that research activities integrate seamlessly with standard patient care operations. Evaluates incoming trial protocols for operational feasibility, resource availability, and patient accrual potential across the entire healthcare system network. Drives financial sustainability while expanding patient access to cutting-edge clinical therapies. Ensures strict regulatory compliance with FDA and HIPAA standards and aligns trial operations between health system and satellite clinics. Partners with Principal Investigators (PIs), department chairs, and medical directors to support investigator-initiated studies and industry-sponsored trial portfolios.

Degrees:

• Masters

Additional Qualifications:

• Advanced scientific or clinical degree (Ph.D., M.D., D.O.) preferred.
• 10 years of progressively responsible experience in clinical research operations, with at least 5 years in a dedicated leadership/managerial role in a pharmaceutical, biotech, or healthcare organization.
• Active certification as a Certified Clinical Research Professional (CCRP via SOCRA) or Certified Clinical Research Coordinator/Manager (CCRC/CCRM via ACRP) preferred.
• Comprehensive knowledge of FDA regulations, Department of Health and Human Services (DHHS) policies, ICH-GCP (Good Clinical Practice) guidelines, and Medicare research billing rules.
• Advanced proficiency with Clinical Trial Management Systems (CTMS) and enterprise EHR platforms.
• Exceptional negotiation skills with a deep understanding of clinical trial agreements (CTAs) and corporate budgeting templates.
• Proven track record managing diverse therapeutic portfolios, including high-acuity specialties (e.g., Cardiovascular, Oncology) and outpatient preventative registries.
• Must possess medical or bioscientific, business, grant/promotional writing and presentation skills.
• Demonstrates strong planning, management, organization and analytical skills.
• Requires extensive amount of initiative, analytical and evaluation efforts and constructive thinking to develop alternatives for resolution to frequently changing and difficult situations.

Minimum Required Experience: 10 Years