AdventHealth - Orlando, FL

posted 4 months ago

Full-time - Mid Level
Orlando, FL
Hospitals

About the position

The Research Compliance Analyst at AdventHealth Research Institute (AHRI) plays a crucial role in ensuring that research activities are conducted in compliance with applicable federal, state, and local regulations. This position is responsible for implementing the Research Compliance Program by conducting compliance research, reviewing regulations, and synthesizing industry publications. The Analyst will assist in developing training materials and guidance documents for the department, contributing to the risk assessment of the Research Compliance Program, and addressing compliance-related inquiries and investigations. In this role, the Research Compliance Analyst will operate independently, conducting regular, ad hoc, and for-cause audits to monitor compliance with laws, regulations, and AHRI Policies & Procedures. The Analyst will provide detailed reports of findings, assist in Root Cause Analysis (RCA), and develop Corrective and Preventative Action (CAPA) plans to ensure that any compliance issues are resolved effectively. The position requires collaboration with the Research Compliance Manager to prioritize and coordinate audits, and it involves travel to various AH campuses for onsite audits. The Analyst will document findings objectively and communicate required actions to bring projects into compliance. They will also guide research departments and investigators in conducting RCAs and developing CAPAs based on audit results. This role emphasizes outstanding customer service and maintaining respectful relationships with all stakeholders involved in the research process.

Responsibilities

  • Assist with the implementation of the Research Compliance Program by conducting compliance research and reviewing regulations.
  • Develop training materials and guidance documents for the department.
  • Conduct regular, ad hoc, and for-cause audits to monitor compliance with applicable laws and regulations.
  • Document findings objectively via audit reports and identify required actions for compliance.
  • Provide one-on-one and informal training to Principal Investigators (PIs) and study team members regarding audit findings.
  • Guide research departments in conducting Root Cause Analyses (RCAs) and developing Corrective and Preventative Action (CAPA) plans.
  • Conduct follow-up on action items identified in audit reviews to ensure timely resolution.

Requirements

  • Bachelor's degree in life sciences, including Medical Research, Nursing, or a related healthcare field with five years of clinical research experience; or an Associate degree in healthcare with seven years of clinical research experience.
  • Research certification through a professional research organization such as SOCRA, ACRP, or SRA.

Nice-to-haves

  • Current active State of Florida Registered Nurse license or other relevant professional licensure.
  • Certification in Healthcare Research Compliance (CHRC) through the Compliance Certification Board.

Benefits

  • Paid Days Off from Day One
  • Student Loan Repayment Program
  • Career Development
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