Director, Clinical Research Operations and Strategy

Location:

8901 CARTI Way, Little Rock, AR, , United States. Job Category:
Leadership. Employee Type:
Exempt Full Time.

The Director of Clinical Research Operations and Strategy is a senior business and program leadership role responsible for the development, execution and growth of CARTI's clinical research enterprise to serve a diverse and geographically dispersed population, including rural and underserved communities. In co‑leadership with the Medical Director of Clinical Research and reporting directly to the Chief Clinical Officer, this position serves as the operational and strategic anchor of the CARTI research pillar — translating scientific opportunities into an executable, financially sustainable, and sponsor‑attractive trial portfolio.

This role collaborates closely with the executive leadership, including the CFO, physician investigators, and external partners to align research strategy with organizational priorities and ensure scalable, high‑quality program performance.

• Develop and manage CARTI's clinical trial portfolio, evaluating studies for scientific alignment, financial viability, and operational feasibility
• Collaborate with executive and clinical leadership to define research strategy, growth priorities, and new program development
• Support expansion into emerging areas, including theranostics, bispecifics, device‑based therapies, and precision medicine
• Cultivate and maintain relationships with pharmaceutical sponsors, biotech companies, device manufacturers, and contract research organizations (CROs) to position CARTI as a preferred investigational site
• Lead site qualification and feasibility processes for sponsor‑initiated studies
• Serve as the primary operational liaison for external research partnerships
• Oversee day‑to‑day research program operations including study activation, patient enrollment performance, data quality, and protocol compliance across all active trials
• Partner with investigators to align research opportunities and support investigator‑initiated trial development
• Direct the research operations team establishing performance standards, workflows, and capacity planning
• Ensure that all CARTI research‑related committees (CSSC, PRMC, Genetic/Genomic, Grant and Publication Committees) operate as a coordinated system aligned with strategic priorities, regulatory requirements and operational efficiency.
• Develop and manage the research program budget, including trial‑level financial modeling
• Lead sponsor contract and budget negotiations
• Oversee Medicare Coverage Analysis and ensure compliant billing practices
• Monitor KPI and prepare financial reporting on research program performance for leadership
• Identify and pursue federal, state, and foundation grant opportunities (e.g. NCORP, FDA‑funded initiatives, and rural health research initiatives)
• Lead or co‑lead grant applications and funding strategies
• Manage grant reporting, compliance, and financial reconciliation
• Ensure compliance with GCP, FDA regulations, IRB requirements, and institutional SOPs across all active studies
• Maintain high standards for data integrity, audit readiness, and regulatory adherence

Yes.

• Bachelor's degree in health sciences, life sciences, business, or related field;
  Master's degree (MPH, MS, MHA, MBA) with clinical/research foundation, preferred
• CCRP (Certified Clinical Research Professional) CCRC, or equivalent certification preferred

• Minimum seven (7) years of clinical research experience, including five (5) years in a leadership role.
• Demonstrated success in building, scaling and managing a clinical trial portfolio, including sponsor‑facing business development or site selection participation
• Strong working knowledge of GCP, FDA regulatory framework, IRB processes, and Medicare Coverage Analysis
• Experience with clinical trial budget development and sponsor contract negotiation
• Strong communication and relationship management skills; ability to engage credibly with sponsors, physician investigators, executive leadership, and external funders
• Experience with NCI NCORP,…