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

Baptist Health; Miami (FL); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Career growth

Health resources and wellness

Wellness program

Tuition reimbursement

Professional development

Job summary

Baptist Health in Florida seeks an experienced leader to provide strategic, operational, financial, and regulatory oversight for cardiovascular clinical trial activities across its hospitals and clinics. You will standardize workflows, guide patient recruitment, and align trial operations with patient care, ensuring regulatory compliance with FDA and HIPAA.

Lead a team of clinical research coordinators, partner with PIs and department chairs, and expand investigator-initiated and

Qualifications

• 10+ years in clinical research operations
• 5+ years in leadership/management
• CCRP/CCRM preferred
• FDA/ICH-GCP knowledge
• Proficient CTMS and EHR experience

Responsibilities

• Provide strategic, operational, financial and regulatory oversight for cardiovascular clinical trial activities across health system.
• Standardize clinical trial workflows and patient recruitment strategies.
• Ensure regulatory compliance with FDA and HIPAA standards.
• Lead and develop clinical research coordinators and collaborate with PIs and medical directors.
• Expand investigator-initiated studies and industry-sponsored trial portfolios.

Skills

Leadership

Strategic planning

Regulatory compliance

Clinical research

Negotiation

Education

Masters

Advanced degree

Tools

CTMS

EHR systems

Job description

Baptist Health is the region's largest not-for-profit healthcare organization, with 12 hospitals, over 29,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices across Miami-Dade, Monroe, Broward and Palm Beach counties. With internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences, Baptist Health is supported by philanthropy and driven by its faith-based mission of medical excellence. For 26 years, we've been named one of Fortune's 100 Best Companies to Work For, and in the 2025-2026 U.S. News & World Report Best Hospital Rankings, Baptist Health was the most awarded healthcare system in South Florida, earning 63 high-performing honors.

What truly sets us apart is our people. At Baptist Health, we create personal connections with our colleagues that go beyond the workplace, and we form meaningful relationships with patients and their families that extend beyond delivering care. Many of us have walked in our patients' shoes ourselves and that shared experience fuels out commitment to compassion and quality. Our culture is rooted in purpose, and every team member plays a part in making a positive impact – because when it comes to caring for people, we're all in.

Benefits

• Career growth and development opportunities, with clear pathways and ongoing support
• Comprehensive health and wellness resources that go beyond traditional benefits
• A wellness program that can help employees eliminate their medical plan deductible, reducing out-of-pocket healthcare costs
• Tuition reimbursement to support continued learning and advancement
• And so much more

Together, these benefits and others reflect our commitment to caring for our people, so they can build fulfilling careers with us while making a meaningful impact every day.

Description

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.

Qualifications

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

EOE, including disability/vets