Research Compliance Specialist Sr.

Tampa General Hospital•Tampa, FL

12d

About The Position

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. Responsible for performing job duties in accordance with mission, vision and values of Tampa General Hospital. 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 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.

Requirements

Bachelor's Degree in Business, Finance, Healthcare Administration, or other related field.
Certified Professional Coder (CPC) offered by the American Academy of Professional Coders, Certified Coding Specialist (CCS) offered by the American Academy of Professional Coders, Registered Health Information Administrator (RHIA) offered by The American Health Information Management Association (AHIMA), Registered Health Information Technician (RHIT) offered by The American Health Information Management Association (AHIMA), or Clinical Research Certification offered by Health Care Compliance Association (HCCA) certification.
Three (3) years of recent work experience in finance, accounting, or clinical research compliance and billing.
A research compliance certification is required or must be obtained within 18 months of employment.
Financial audit/billing compliance experience.
Thorough knowledge and understanding of regulatory guidelines Department of Justice, Health and Human Services Centers for Medicare & Medicaid.
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.

Responsibilities

Coordinates all financial and billing monitoring of the Research Compliance Research Billing/Finance Review (RBFR) program.
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.
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 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.
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.