Job Summary

The Clinical Research & Financial Analyst provides analytical, operational, financial and regulatory support for clinical research studies and programs at Tenet Health. This position assists investigators and research teams in the planning, implementation, monitoring, contracting, and reporting of clinical research activities while ensuring compliance with federal regulations, institutional policies, and study protocols. This position analyzes clinical and research data, prepares reports, supports regulatory submissions, and contributes to the successful execution of clinical trials and observational research.

Responsibilities

• Analyze clinical research data to identify trends, ensure data integrity, and support research objectives.
• Ability to make financial/business decisions based on complex protocols and long-range financial projections. Knowledge on applications of principles and practices of fiscal planning and analysis.
• Assist with negotiation of clinical research budgets with industry sponsors, federal agencies, and private foundations. Responsibilities include providing a Medicare coverage analysis and billing analysis based on a review of the study protocol, contract, budget, and informed consent form (as it relates to payment of study expenses), and implementing a Documented Billing Plan for each protocol. 
• Responsible for assessing the structure of financial management of clinical research projects.
• Knowledge of Federal standards of governance, including the FDA, NCI, OHRP and broader Department of Health and Human Services standards as may apply to clinical practice with investigational agents and research with human subjects.
• Assist in the development, implementation, and monitoring of clinical research protocols and study procedures.
• Maintain accurate clinical research databases and ensure completeness and quality of study data specific to clinical trial management software.
• Prepare reports, dashboards, summaries, and presentations for investigators, sponsors, and leadership.
• Support Institutional Review Board (IRB) submissions, regulatory documentation, and study compliance activities.
• Monitor study progress to ensure adherence to budgets
• Collaborate with physicians, investigators, research coordinators, statisticians, and other multidisciplinary team members.
• Perform quality assurance reviews and assist with internal audits to ensure compliance with Good Clinical Practice (GCP), FDA regulations, HIPAA, and institutional policies.
• Track study milestones, enrollment, adverse events, protocol deviations, and research metrics.
• Financial tracking and audits of the accounts including: Reconciliation of accounts, reimbursements and expenditures, accuracy of budget projections, timeliness of payment invoicing and collection, creating financial and retrospective reporting; analyzing patient care costs billed to study or insurance. Implement detail billing payment to track expenditures, payments milestone payments, monthly Quarterly billing of translation invoices to Sponsors or internal departments as well as collections.
• Maintain confidential research records and safeguard protected health information.
• Recommend process improvements that enhance research quality, efficiency, and compliance.
• Mentor, coach, train and educate, as appropriate all advocate constituents to ensure strict compliance with clinical research billing regulations. Responsible for assuring the financial compliance of the program as stipulated by the study sponsor, federal, state, and local agencies.
• Perform other related duties as assigned.
• Occasional evening or weekend work may be required to support research activities or study deadlines.

Qualifications

Minimum

• Bachelor's degree 
• Two (2) years of experience supporting clinical research, healthcare analytics, regulatory compliance, or research administration.
• Experience working with research databases and Microsoft Office applications, particularly Excel.
• Knowledge of clinical research methodologies, data management principles, and regulatory requirements.
• Strong analytical, organizational, and problem-solving skills.
• Ability to make financial/business decisions based on complex protocols and long-range financial projections. Knowledge on applications of principles and practices of fiscal planning and analysis.
• Knowledge of Federal standards of governance, including the FDA, NCI, OHRP and broader Department of Health and Human Services standards as may apply to clinical practice with investigational agents and research with human subjects.
• Excellent written and verbal communication skills.
• Ability to manage multiple projects while meeting deadlines.
• Knowledge of Good Clinical Practice (GCP), FDA regulations, HIPAA, and human subject protections.
• Ability to interpret clinical protocols, research regulations, and technical documentation.
• Ability to analyze financial data and protocols and create subsequent contracts. 
• Strong quantitative and qualitative data analysis skills.
• Excellent attention to detail and commitment to data quality.
• Ability to work independently and collaboratively within multidisciplinary teams.
• Effective project management and organizational skills.
• Proficiency with Microsoft Office Suite and research management software.
• Strong interpersonal skills and the ability to communicate effectively with investigators, research staff, sponsors, and participants.

Preferred

• Experience with clinical trial management systems (e.g. Clinical Conductor).
• Knowledge of statistical software such as SAS, SPSS, R, or Python.
• Experience with grant-funded or academic research programs.

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