Research Compliance Specialist Sr.
Tampa General Hospital
Summary
Under the guidance of the Manager of Research Compliance, the Senior Research Compliance Specialist coordinates all financial and billing monitoring of the Research Compliance Research Billing/Finance Review (RBFR) program. The Sr. Research Compliance Specialist serves as a departmental representative by promoting and implementing required compliance programs for specific departments and/or service lines, performs compliance reviews, communicates with internal and external customers, organizes and maintains logs of monitored program elements including compliance/privacy calls, government inquiries, and training. This position directly supports the Research Compliance Manager.
Job description
Essential Functions
- Serves as a resource for investigators and clinical research staff.
- Carries out responsibilities in accordance with the organizations policies, departmental standards and applicable laws.
- Collaborates with the research management team and staff, and assists in training and teaching team members.
- Assists, when assigned, with sponsors and FDA audits and audit responses.
- Teaches and mentors research staff.
- Develops training materials and monitoring tools, reviews and revises system-wide policies and procedures.
- Participates in the administrative, compliance and training processes of the research team.
- Ensures that clinical trials are generated, documented and reported in compliance with internal SOPs, GCP guidelines, sponsor guidelines and current applicable regulatory regulations.
- Implements policies, procedures and provides training efforts for team member(s).
- Supports a culture of compliance and integrity in the TGH clinical research enterprise.
- The Senior Compliance Specialist must rely upon experience and judgement to plan and accomplish goals.
- Participates in the creation and review of tools utilized by the Research Compliance Program to complete its responsibilities.
- Creates educational content for the research education/training activities at TGH across multiple therapeutic areas.
- Serves as a departmental representative by promoting and implementing required compliance programs for specific departments and/or service lines, performs compliance reviews, communicates with internal and external customers, organizes and maintains logs of monitored program elements including compliance/privacy calls, government inquiries, and training.
Technical Knowledge, Skills, and Abilities
- Financial audit/billing compliance experience.
- Thorough knowledge and understanding of regulatory guidelines Department of Justice, Health and Human Services Centers for Medicare & Medicaid.
- Requires a working knowledge of Microsoft Office and electronic clinical trial management systems (CTMS).
- Experience implementing and working with multiple research related IT systems.
- Well-developed organizational skills and detail oriented.
- Goal oriented person who takes initiative, is self-motivated and a creative problem solver.
- Able to do a financial and logistical review of protocols and apply this knowledge to billing compliance monitoring/compliance auditing.
Requirements
- Bachelor's Degree in Business, Finance, Healthcare Administration, or other related field.
- Compliance Certification required through CHRC, HCCA.
- Three (3) years of recent work experience in finance, accounting, or clinical research compliance and billing.
- Financial audit/billing compliance experience.
- Thorough knowledge and understanding of regulatory guidelines Department of Justice, Health and Human Services Centers for Medicare & Medicaid.
- Requires a working knowledge of Microsoft Office and electronic clinical trial management systems (CTMS).
- Experience implementing and working with multiple research related IT systems.
- Well-developed organizational skills and detail oriented.
- Goal oriented person who takes initiative, is self-motivated and a creative problem solver.
- Able to do a financial and logistical review of protocols and apply this knowledge to billing compliance monitoring/compliance auditing.
Company overview
Tampa General Hospital is a leading academic medical center and regional healthcare system located in Tampa, Florida. As one of the largest hospitals in Florida, it serves as the primary teaching hospital for the University of South Florida Morsani College of Medicine. The hospital operates a comprehensive Level I trauma center, providing the highest level of trauma care available. Tampa General Hospital is nationally recognized for its expertise in organ transplantation, with one of the busiest transplant programs in the United States. The institution offers a wide range of specialized services including cancer care, cardiovascular medicine, neurosciences, women's health, and pediatric services. With its commitment to medical education and research, Tampa General Hospital plays a crucial role in advancing healthcare through clinical trials and innovative treatments. The hospital system includes multiple specialty centers and outpatient facilities throughout the Tampa Bay region, serving as a vital healthcare resource for millions of residents in West Central Florida.