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
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 researchcompliance support staff.
·Identifies and assigns specific clinical trials for auditing by theResearch ComplianceAnalysts and ensures the timely completion and accurate reporting of auditingresults.
·Oversees and may conduct onsite audits of selected research programs/studies and/or internal processes forthe 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 faceof severe audit findings, the Research Compliance Manager may place a studyon administrative hold per P&P, at the time of point of discovery to preventadditional/further noncompliance.
What You Will Need:
KNOWLEDGE AND SKILLSREQUIRED:
·Expertise of the federal oversight agencies, and otherbodies, governing research and their applicable federal regulations or standards, including, but not limitedto, theOfficeofHumanResearchProtection(OHRP),InternationalConferenceonHarmonization(ICH), FoodandDrugAdministration(FDA),OfficeorResearchIntegrity(ORI),NationalInstitutesofHealth (NIH),OfficeofInspectorGeneral(OIG),OfficeofManagementandBudget(OMB),HIPAAPrivacy RulesandRegulationsastheyrelatetoresearch,localInstitutionalReviewBoard(IRB),CentralIRBs, and local research administration review and approvalprocesses.
·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) plansandmonitor them assessing for completeness andeffectiveness
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 REGISTRATIONPREFERRED:
·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
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.
At AdventHealth, Extending the Healing Ministry of Christ is our mission. It calls us to be His hands and feet in helping people feel whole. Our story is one of hope — one that strives to heal and restore the body, mind and spirit. Our more than 80,000 skilled and compassionate caregivers in hospitals, physician practices, outpatient clinics, urgent care centers, skilled nursing facilities, home health agencies and hospice centers are committed to providing individualized, wholistic care.