Description

Research Compliance Manager

Location Address: 601 E. Rollins St., Orlando, FL 32801

Top Reasons to work at AdventHealth Orlando

• Located on a lush tropical campus, our flagship hospital, 1,368-bed AdventHealth Orlando

• serves as the major tertiary facility for much of the Southeast, the Caribbean and South America

• AdventHealth Orlando houses one of the largest Emergency Departments and largest cardiac catheterization labs in the country

• We are already one of the busiest hospitals in the nation, providing service excellence to more than 32,000 inpatients and 125,000 outpatients each year

Work Hours/Shift:

• Full Time, Days

You Will Be Responsible For:

· The Research Compliance Manager is responsible for the daily management of the Research Compliance Analysts and the research compliance support staff.

· Identifies and assigns specific clinical trials for auditing by the Research Compliance Analysts and ensures the timely completion and accurate reporting of auditing results.

· Oversees and may conduct onsite audits of selected research programs/studies and/or internal processes for the purpose of compliance with research regulations and institutional policies.

· The Research Compliance Manager provides support and direction to the Research Compliance Analysts, and the research team during auditing visits. In the face of severe audit findings, the Research Compliance Manager may place a study on administrative hold per P&P, at the time of point of discovery to prevent additional/further noncompliance.

Qualifications

What You Will Need:

KNOWLEDGE AND SKILLS REQUIRED:

· Expertise of the federal oversight agencies, and other bodies, governing research and their applicable federal regulations or standards, including, but not limited to, the Office of Human Research Protection (OHRP), International Conference on Harmonization (ICH), Food and Drug Administration (FDA), Office or Research Integrity (ORI), National Institutes of Health (NIH), Office of Inspector General (OIG), Office of Management and Budget (OMB), HIPAA Privacy Rules and Regulations as they relate to research, local Institutional Review Board (IRB), Central IRBs, and local research administration review and approval processes.

· Thorough knowledge and understanding of federal rules and regulations applicable to research billing compliance, including the False Claims Act, Anti-Kickback Statute, the Medicare Clinical Trials Policy – National Coverage Determination (NCD) for Routine Costs in Clinical Trials, and Medicare Benefit Policy Manual, Ch. 14.

Skilled in leading teams to develop meaningful and applicable Corrective and Preventative Action (CAPA) plans and monitor them assessing for completeness and effectiveness

LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:

· Certification in research compliance from the Health Care Compliance Association (HCCA), Certified in Healthcare Research Compliance (CHRC)

LICENSURE, CERTIFICATION OR REGISTRATION PREFERRED:

· Additional professional research certification through any professional research organization such as The Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), or Public Responsibility in Medicine and Research (PRIM&R)

EDUCATION AND EXPERIENCE REQUIRED:

· Bachelor’s degree in legal studies, research administration, healthcare administration, business administration, biomedical, science, or research-related field

· Minimum three (3) years of research compliance related responsibilities with at least two (2) years of experience conducting and/or overseeing internal audits or investigations of research studies, processes, and/or research billing.

· Minimum of two (2) years of experience managing employees

· Minimum of two (2) years of experience in writing policies, procedures, guidance documents, and/or standard operation procedures in the area of research

· Minimum of five (5) years of experience in the interpretation and application of federal regulations, policies/procedures, and ethical principles related to research compliance

· Research Compliance Program Development experience including conducting a risk assessment and developing an annual work plan

· Experience handling complex investigations

· Experience with Investigator Initiated Studies (IIS)

· Experience in developing educational presentations and public speaking

Job Summary:

AdventHealth Research Institute (AHRI) provides research oversight at the corporate level across all markets to ensure that research is consistently performed in full alignment with all applicable federal, state, and local rules and regulations. The Research Compliance Manager is responsible for oversight planning for onboarding new markets and maintaining an oversight program that ensures human subject safety, compliance with all federal regulations related to research billing, and maintaining AdventHealth’s reputation as an influential brand and as a leader in research.

This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.

Category: Research

Organization: AdventHealth Orlando

Schedule: Full-time

Shift: 1 - Day

Req ID: 23031349

We are an equal opportunity employer and do not tolerate discrimination based on race, color, creed, religion, national origin, sex, marital status, age or disability/handicap with respect to recruitment, selection, placement, promotion, wages, benefits and other terms and conditions of employment.