Senior Manager Research Compliance & Training
All the benefits and perks you need for you and your family:
Benefits from Day One
Paid Days Off from Day One
Debt-free Education* (Certifications and Degrees without out-of-pocket tuition expense)
Our promise to you:
Joining AdventHealth is about being part of something bigger. It’s about belonging to a community that believes in the wholeness of each person, and serves to uplift others in body, mind and spirit. AdventHealth is a place where you can thrive professionally, and grow spiritually, by Extending the Healing Ministry of Christ. Where you will be valued for who you are and the unique experiences you bring to our purpose-minded team. All while understanding that together we are even better.
Schedule: Full Time
Shift: M-F 8-5 Hybrid, in office no more than 2 days/week, could be as little as once or twice per month
The community you’ll be caring for: 800 N MAGNOLIA AVE, Orlando, 32803
The role you’ll contribute:
AdventHealth Research Institute (AHRI) provides corporate level research oversight across all markets to ensure that research is performed in a consistent manner that is in full alignment with all applicable federal, state, and local rules and regulations. The Research Compliance & Training Senior (Sr.) Manager is responsible for oversight plans for onboarding markets and maintaining an oversight program that ensures both human subject safety and AdventHealth's reputation as a leader in research. The Research Compliance & Training Senior (Sr.) Manager has direct responsibility for the internal research auditing and monitoring team and the research Conflicts of Interest program. Additionally, the Research Compliance & Training Sr. Manager has responsibility to ensure required research training for research compliance and responsible conduct in research is developed and implemented and provides support in the establishment of the research professional development curriculum. The Research Compliance & Training Sr. Manager has expert knowledge in the areas of state and federal laws and regulations, research ethics, institutional policies, and other agency requirements which govern the conduct of research, the protection of human subjects in research, and grant program requirements.
The value you’ll bring to the team:
Manages the Research Compliance, COI, and Research Training & Education leaders.
Manages the Research COI program which is a corporate level function to manage and/or eliminate any research related COIs and ensure that adequate and appropriate management plans are implemented to avoid any potential bias in research related to financial COIs.
Accountable for the administrative direction and management, implementation, and execution of the Research Compliance Program which is a corporate level function providing oversight of research across the healthcare system.
Accountable for ensuring compliance and providing evidence of performance. Maintains effective and consistent communication with customers.
Performs ongoing risk assessments of research-related policies, procedures, training programs, etc. Analyzes whether there are any gaps and determines timeframes and resources necessary to address any gaps.
Responsible for the oversight of the research compliance team activities including accountability for the execution of auditing and monitoring activities related to the annual research compliance work plan.
Reviews monitor and audit findings and reports escalating as appropriate to leadership team.
Leads and develops new and revised corporate-wide research compliance related and Human Research Protection Program (HRPP) policies and procedures (P&P), to comply with federal regulations, AAHRPP standards and AHRI policies.
Serves as Research Oversight Committee Ex-Officio member and is accountable to ensure all research compliance and COI related quarterly reports are submitted to ROC.
Provides expert opinion and counsel to research leadership, investigators and coordinators on compliance with federal laws and the AHRI Research Compliance and HRPP Policies and procedures.
The expertise and experiences you'll need to succeed:
EDUCATION AND EXPERIENCE REQUIRED:
Master’s degree or Bachelor’s degree in legal studies, research administration, healthcare
administration, business administration or research-related field
Minimum four years of research compliance related responsibilities
Minimum of four years of experience in a management position providing program management and/or staff management in a bio-medical or clinical research area
Experience in managing conflicts of interest, preferably in an academic medical center or large healthcare system
Minimum of seven years of experience in the interpretation and application of federal regulations, policies/procedures, and ethical principles related to research compliance
Prior experience managing personnel
Research compliance program development experience
Extensive experience handling complex investigations
Experience in developing high-impact presentations, presenting effectively to senior and executive leaders
Interested candidates apply online at: http://link.adventhealth.com/tp/rj6.X1WMs.e_K
This facility is an equal opportunity employer and complies with federal, state and local anti-discrimination laws, regulations and ordinances.