Clinical Research Site Director, Axiom Brain Health
Reports To: Director, GAP Owned & Operated Sites Location: On-site, Tampa, FL
Position Summary
Join an organization dedicated to transforming the future of neurological healthcare through groundbreaking clinical research. Our site specializes in advancing innovative therapies and diagnostics for Alzheimer's disease and Related Dementias (ADRD), Parkinson's disease (PD), Multiple Sclerosis (MS), and other neurological disorders. We are committed to improving the lives of patients and families by providing access to cutting-edge clinical trials while delivering the highest standards of quality, ethics, and participant care.
Axiom Brain Health (ABH) is a clinical research site that has been providing exceptional, concierge-level attention to residents in the Tampa-area for 30+ years. We specialize in conducting Phase II-IV neurological clinical trials, such as Alzheimer’s, Parkinson’s, and Multiple Sclerosis, in a comfortable outpatient setting. ABH is owned and operated by the Global Alzheimer’s Platform Foundation (GAP), the leading, global, person-centered, non-profit organization dedicated to speeding the delivery of innovative therapies to those living with CNS conditions like Alzheimer’s and Parkinson’s, by reducing the time and cost of clinical trials.
The Site Director serves as the operational and strategic leader for the clinical research site, providing on the ground leadership for all aspects of clinical trial operations. This highly visible role is responsible for driving operational excellence, developing high-performing teams, fostering sponsor and community relationships, and ensuring the successful execution of a diverse portfolio of CNS clinical trials.
Reporting to Global Alzheimer’s Platform Foundation (GAP) , Owned & Operated Site (GOOS) leadership, the Site Director partners closely with Principal Investigators, physicians, sponsors, CROs, and internal departments to develop innovative operational strategies that improve participant recruitment, retention, study execution, financial performance, and overall site growth. This position offers a unique opportunity to influence the future of neurological clinical research while building an exceptional research program recognized for quality, innovation, and operational excellence.
The ideal candidate is an experienced clinical research leader who thrives in a fast-paced environment, enjoys mentoring team members, embraces innovation, and is passionate about expanding access to life-changing therapies for individuals living with neurological diseases.
Essential Job Functions
- Oversight of the day-to-day operations of clinical research operations, ensuring operational excellence of the site including the management of staff.
- Collaborate with Principal Investigators and site physicians to ensure appropriate resources are in place for effective clinical trial operations.
- Develop and execute strategic initiatives that support organizational growth, operational efficiency, participant satisfaction and sponsor success.
- Build, mentor, coach, and develop a high-performing team while fostering a culture of collaboration, accountability, innovation, and continuous improvement.
- Maintain an up-to-date clinical site profile to highlight the site's capabilities, therapeutic expertise, performance metrics, and other applicable resources to support continued efforts in gaining additional clinical trials from sponsors, vendors, and stakeholders.
- Oversee calibration, maintenance, and readiness of all equipment..
- Oversee all aspects of the clinical trial execution from feasibility through study close-out while ensuring timelines, quality standards and participant safety is achieved throughout the entire trial.
- Complete feasibility assessments, participate in Pre-Selection and Selection Visits, and oversee study start-up activities to accelerate site activation.
- Ensure appropriate staffing and coordination through fluid and effective communication across teams: recruiters, outreach coordinators, study coordinators, laboratory staff, data personnel, infusion/pharmacy staff, and investigators.
- Partner with GOOS leadership to establish annual operational goals, key performance indicators (KPIs) and long-term strategic goals.
- Partner with central functions including Finance, Regulatory, Compliance, Marketing, and HR on continued performance and improvements at the site.
- Assist with budget management and promote responsible fiscal stewardship.
- Ensure compliance with all applicable FDA regulations, ICH-GCP guidelines, HIPAA, sponsor requirements, federal, state, and institutional regulations.
- Lead development, implementation and routine review of site Standard Operating Procedures (SOPs), work instructions and quality improvement initiatives.
- Create and foster a culture of inspection readiness through proactive quality management, risk assessment, and continuous process improvement.
- Oversee HR responsibilities including hiring, staff management, mentorship, and guidance.
- Monitor and present revenue, enrollment performance, performance metrics, and strategies to leadership.
- Champion innovative approaches and maintain community partnerships, physician outreach, and other novel approaches to strengthen recruitment and retention at the site.
- Evaluate, select, and oversee external vendors supporting site operations.
- Cultivate partnerships with community organizations such as healthcare providers (HCP), advocacy organizations, support groups, community groups, and other potential referral partners to expand recruitment and referral source networks.
- Drive diversity and inclusion initiatives that improve representation across clinical trials at the site.
- Continuously monitor emerging clinical research best practices to enhance the site’s performance.
- Serve as a trusted resource to sponsors, CROs, and organizational leadership while representing the organization at investigator meetings, conferences and industry events.
- Perform additional duties as assigned to support organizational objectives and continued site success.
Education and Experience
- Bachelor’s degree required; Master’s degree preferred.
- 5+ years of Clinical Research experience.
- 2+ years of personnel management experience.
- Experience managing CNS, neurology, Alzheimer’s disease, Parkinson’s disease, or other neurodegenerative clinical trials or equivalent preferred.
- ACRP (CCRC), SoCRA (CCRP), or equivalent clinical research certification is strongly preferred.
- Bilingual English/Spanish preferred.
Knowledge, Skills, Abilities
- Comprehensive knowledge of FDA regulations, ICH-GCP, HIPAA, and clinical research operations.
- Strong understanding of CNS clinical trials, participant recruitment strategies, study execution and clinical trial operations.
- Demonstrate ability to lead, mentor, and develop high-performing teams.
- Exceptional leadership, organizational, and strategic planning skills.
- Proficiency in Microsoft Office, Google Suites, eSource, eRegulatory platforms, CTMS platforms, EDC systems, IWRS/IVRS applications and other sponsor provided applications.
- Excellent oral and written communication skills.
- Ability to foster strong relationships with investigators, staff, sponsors, CROs, community partners, and healthcare providers.
- Ability to manage multiple priorities while problem-solving and maintaining exceptional attention to detail and regulatory compliance.
- Analytical and problem-solving skills with keen attention to detail.
- Passionate about advancing neurological research and improving the lives of people through innovation.
Why Join Our Team?
- Lead one of the region's premier neurology-focused clinical research programs
- Make a meaningful impact by advancing therapies for Alzheimer's disease, Parkinson's disease, Multiple Sclerosis, and other neurological disorders
- Collaborate with industry leaders in the execution of innovative research trial.
- Shape the strategic direction and growth of a high-performing clinical research site
- Influence innovation in participant recruitment, community engagement, and clinical trial delivery
- Enjoy opportunities for professional development, leadership growth, industry engagement, and continued career advancement
What Success Looks Like
During the first 12 months, the successful Director will:
- Build and develop a highly engaged, high-performing clinical research team.
- Strengthen sponsors, CROs, and community partners relationships while expanding business opportunities.
- Improve participant recruitment, enrollment, and retention across the site’s study portfolio.
- Maintain exceptional quality and regulatory compliance while ensuring continuous inspection readiness.
- Enhance operational efficiency, financial performance, and study execution metrics.
- Expand community partnerships that increase awareness of clinical research and improve participant access to innovative therapies.
Pay: $115,000.00 - $150,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Parental leave
- Professional development assistance
- Retirement plan
- Tuition reimbursement
- Vision insurance
Work Location: In person
