Director, Clinical Research Administration (Remote from Florida)

About the position The Director of Clinical Research Administration provides strategic and administrative leadership for the planning, management, and execution of clinical research business and operational activities supporting the clinical research program at Florida Cancer Specialists & Research Institute. This role ensures studies are conducted in accordance with regulatory requirements and sponsor expectations while driving operational performance, program growth, and team development across the clinical research enterprise. Responsibilities • Provide strategic and operational leadership for clinical research activities across the organization, ensuring studies are conducted in accordance with regulatory requirements, sponsor expectations, and institutional policies. • Monitor operational performance across the research program, including study activation timelines, enrollment performance, key performance indicator (KPI) monitoring, and operational efficiency, implementing process improvements as needed. • Support alliance management activities with key industry partners to maintain strong sponsor relationships and promote continued research collaboration and portfolio growth. • Ensure alignment on study execution, operational expectations, and performance metrics across sponsor and CRO partnerships. • Direct vendor strategy and oversight for clinical research operations, including selection, contracting support, performance monitoring, and relationship management for vendors supporting clinical trial execution (including CTMS, eRegulatory platforms, imaging providers, and specialty service vendors). • Lead the preparation, negotiation, and management of clinical trial agreements, confidentiality agreements, and related research contracts in collaboration with sponsors and internal stakeholders. • Provide hands-on grant management, including preparing budgets, submitting applications, tracking award progress, and preparing required progress reports. • Support contract and study budget negotiation activities to ensure study budgets appropriately reflect operational costs and resource utilization. • Support research billing compliance processes, including research billing determinations and coordination with compliance and revenue cycle teams. • Read and interpret Medicare Coverage Analysis and Code and Coverage determinations to support appropriate setup of research-related billable procedures. • Cultivate strong partnerships with physician investigators to advance clinical research participation, supporting study feasibility, portfolio growth, and enrollment performance. • Partner with the VP of Clinical Research, Medical Directors, investigators, and research staff to identify opportunities to improve patient screening, study awareness, and enrollment in clinical trials. Requirements • Masters degree in Healthcare, Research, or related field • Minimum of 8 years of clinical research experience. Required. • Oncology clinical trials experience required, therapeutic clinical trial experience preferred. • Demonstrated leadership and/or management experience required. • Working knowledge of federal, state, and local regulations governing clinical research, including IRB requirement and research compliance. • Working knowledge of research billing determinations and coverage analysis processes. • Essential competencies and KSAs targeted to successfully performing in role: Clinical Research Expertise: Comprehensive knowledge of clinical research operations, including study start-up, regulatory submissions, patient recruitment, and trial execution. Strong understanding of Good Clinical Practice (GCP), FDA regulations, and human subject protection requirements governing clinical trials. Familiarity with the clinical trial lifecycle, including feasibility assessment, study activation, enrollment management, and study closeout. • Research Compliance and Billing: Knowledge of research billing compliance requirements, including coverage analysis and billing determinations. Understanding of clinical trial financial workflows, including budgeting, invoicing, sponsor payments, and reconciliation. • Contract & Grant Management: Knowledge of clinical trial agreements, confidentiality agreements, and research contracting processes. Familiarity with grant management processes, including proposal submission, award tracking, and reporting requirements. Ability to support or lead study budget development and contract negotiations. • Operational & Leadership Skills Strong analytical and critical thinking skills. Strong project management and operational planning skills. Ability to analyze operational and financial data and track program performance metrics. Demonstrated ability to lead and develop multidisciplinary research teams. Ability to manage competing priorities, drive operational efficiency, and support organizational growth • Communication & Collaboration: Strong interpersonal and communication skills with the ability to effectively collaborate with investigators, research staff, sponsors, and organizational leadership. Ability to facilitate physician engagement and promote participation in clinical research activities. • Technical Systems Knowledge Familiarity with clinical research technology platforms, including CTMS, eRegulatory, and electronic data capture systems. • Valid Driver’s License in state of residency for travel to clinics and must comply with the Company Driver Safety Operations and Motor Vehicle Records Check Policy Nice-to-haves • CCRC/CCRP certification (preferred) Benefits • Offering competitive salaries and comprehensive benefits packages to include tuition reimbursement, 401-K match, pet and legal insurance. • Medical and Prescription Drug Coverage • Vision & Dental Insurance • Employee Assistance Program (EAP) • Health Savings Account (HSA) & Flexible Spending Accounts • Paid Time Off (PTO) • 401(k) Retirement Plan • Life Insurance • Tuition Reimbursement • Disability Insurance • Accident Insurance • Critical Illness • Hospital Indemnity • Pet Insurance • Identity Theft • Legal Insurance