Job Description
The Director of Clinical Trials Administration provides operational leadership, management, and oversight of the Clinical Trials Office and sponsored research activities across TMC Health. This position is responsible for clinical trial administration from study start-up through closeout, including regulatory compliance, trial finances, contracting coordination, research workforce development, quality oversight, and operational performance.
The Director collaborates with physician investigators, research leadership, Finance, Compliance, Legal, Quality, Revenue Cycle, Information Technology, and clinical operations to ensure research is safe, compliant, financially sustainable, and integrated into clinical workflows. The role serves as the primary administrative leader for clinical trial execution and supports strategic growth of the organization’s research portfolio.
ESSENTIAL FUNCTIONS
Clinical Trial Operations
· Direct and oversee day-to-day operations of the Clinical Trials Office.
· Ensure timely study start-up, activation, enrollment, monitoring, and closeout activities.
· Develop standardized workflows and operational procedures that support efficient study execution.
· Establish performance metrics for study activation timelines, enrollment, retention, and protocol compliance.
· Monitor operational performance and implement process improvement initiatives.
Regulatory Compliance and Quality Oversight
· Ensure compliance with FDA regulations, ICH Good Clinical Practice, HIPAA, human subject protection requirements, and institutional policies.
· Maintain research readiness for sponsor audits, regulatory inspections, accreditation reviews, and internal reviews.
· Oversee regulatory submissions, continuing reviews, adverse event reporting, and protocol deviation processes.
· Develop and maintain research policies, standard operating procedures, and quality monitoring programs.
· Lead corrective and preventive action plans when compliance issues are identified.
Financial and Business Management
· Oversee clinical trial budgeting, coverage analysis, invoicing, payment reconciliation, and financial reporting.
· Collaborate with Sponsored Projects Accounting on study financial management, sponsor payments, and account reconciliation.
· Monitor research revenues, expenses, and productivity metrics.
· Ensure studies are financially feasible and adequately funded before and during activation.
· Support contract and budget discussions with sponsors, contract research organizations, and funding agencies.
Strategic Program Development
· Support growth and expansion of sponsored, investigator-initiated, and collaborative research programs.
· Identify new research opportunities and operational capabilities that expand service line participation.
· Build working relationships with sponsors, contract research organizations, academic partners, and research networks.
· Participate in strategic planning and business development initiatives related to clinical research.
Leadership and Talent Development
· Recruit, develop, mentor, and evaluate clinical research administration personnel.
· Foster a culture of accountability, compliance, collaboration, participant safety, and continuous improvement.
· Establish performance expectations and productivity standards for staff.
· Support succession planning and professional development for the research workforce.
· Lead regular operational meetings and communication forums.
· Oversight of Sponsored Project Accounting (SPA) team and Disease Group Managers
Collaboration and Stakeholder Engagement
· Serve as a key administrative liaison among physicians, investigators, sponsors, departments, and research personnel.
· Partner with physician research leaders and principal investigators to support successful trial execution.
· Collaborate with Compliance, Legal, Finance, Revenue Cycle, Quality, Information Technology, and clinical operations.
· Present operational and financial metrics to research governance committees and executive leadership.
Adheres to TMCH values of integrity, diversity, accountability, compassion, and teamwork.
Performs related duties as assigned.
MINIMUM QUALIFICATIONS
EDUCATION:
- Bachelor's degree in Health Sciences, Nursing, Business Administration, Healthcare Administration, Public Health, or related field required.
- Master’s degree in Healthcare Administration, Business Administration, Public Health, Clinical Research, or related field preferred.
EXPERIENCE:
- Seven (7) years of progressively responsible experience in clinical research administration or clinical trials operations.
- Three (3) years of leadership experience managing research personnel and operations.
LICENSURE OR CERTIFICATION:
- Good Clinical Practice certificate within 60 days of hire required.
- Certified Clinical Research Professional, Certified Clinical Research Coordinator, or Certified Clinical Research Administrator preferred.
KNOWLEDGE, SKILLS AND KNOWLEDGE:
· Comprehensive knowledge of clinical trial administration and research operations.
· Knowledge of FDA regulations, ICH-GCP guidelines, HIPAA, and human subject protections.
· Experience managing clinical trial finances, budgeting, and contract administration.
· Ability to interpret and apply federal, state, institutional, and sponsor requirements.
· Strong analytical, organizational, communication, and project management skills.
· Ability to manage multiple priorities within a highly regulated environment.
· Demonstrated leadership and personnel management experience.
Ability to perform critical thinking and analysis.
Ability to digest regulatory, industry, and other business guidance, and to communicate and advise necessary actions needed on behalf of the organization.
Ability to demonstrate effective use of computer software tools to assist in accomplishment of duties. (e.g,. IW/XRS, EDC, Excel, Word, Outlook, PowerPoint)
Ability to manage a diverse and demanding workload.
Ability to demonstrate scientific methods.