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Whittier, California
Posted: 07-Nov-23
Location: Orlando, Florida
Salary: Open
Internal Number: 23041299
Description
All the benefits and perks you need for you and your family:
· Benefits from day one
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
The community you’ll be caring for:
800 N MAGNOLIA AVE, Orlando, 32803
The role you’ll contribute:
AdventHealth Research Institute (AHRI) provides research administrative and operational support and 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 Manager Research Support & Quality Assurance has responsibility for research credentialing, management of research conflicts of interest, internal monitoring, and ClinicalTrials.com. This includes ensuring AdventHealth research credentialing requirements are met and maintaining a research Conflicts of Interest (COI) and internal monitoring program that ensures human subject safety, compliance with all applicable federal regulations, and maintaining AdventHealth’s reputation as an influential brand and as a leader in research. The Manager Research Support & Quality Assurance will manage the Clinical Research Monitors, research COI staff and Regulatory Support staff by prioritizing and assigning work and providing orientation and training to new staff. The Manager Research Support & Quality Assurance will contribute to the development, management and reporting of the research compliance program and regulatory functions.
The value you’ll bring to the team:
• Responsible for the daily management of the internal Clinical Research Monitors, Research Conflicts of Interest (COI) staff and Regulatory Support staff including performance, evaluations, development conversations, timekeeping, and workflow of the teams.
• Responsible for management of the COI, Internal Monitoring, Research Credentialing, and ClinicalTrials.gov processes including metrics, reporting and planning.
• Manage the work assignments, priorities, and productivity, including the development of training processes and materials of the teams.
• Accountable for ensuring all AdventHealth Research Conflicts of Interests policies and procedures are followed related to reviewing disclosures, assessing disclosed Significant Financial Interests (SFIs) for research relationship and mitigating factors, development of COI management plans when appropriate, following the defined review process for COI management plans including escalation to the COI Officer, Research Oversight Committee (ROC), and ROC Chair and/or Co-Chair, as appropriate.
• Ensures all COI data and reporting is maintained, prepared, and submitted to the appropriate parties in a timely manner including SFI and Management Plan summary reports, and COI, SFI, and MP quarterly reports.
• Provides guidance and serves as a resource to AHRI research departments and individual research team members regarding AHRI P&Ps and federal regulations related to COI. This may include assisting with content and implementation of COI education and training, conducting live presentations virtual and/or in person at multiple AHRI campuses, and ensuring effective communication and information deployment related to COI.
• Leads in the development and/or revision of AHRI P&Ps related to COI, internal monitoring, ClinicalTrials.gov, required research training per federal regulations.
The expertise and experiences you'll need to succeed:
EDUCATION AND EXPERIENCE REQUIRED:
• Bachelor's degree in healthcare, Science, Nursing, Administration, or a research-related field.
• At least three years’ experience managing research related conflicts of interest.
• Minimum of five years of experience with clinical trials and/or medical research.
• Minimum one year experience in conducting and/or overseeing quality assurance/quality control activities, monitoring of clinical trials, and/or auditing clinical trials for compliance with federal regulations and ICH GCP guidelines.
• Minimum two years of experience in leading employees either through direct management or supervision or by leading a group in the completion of a project.
• Experience in developing educational presentations and public speaking.
EDUCATION AND EXPERIENCE PREFERRED:
• Master’s degree in related field, including Healthcare Administration (MHA), Nursing (MSN), Jurisprudence in Health Law (MJ), Research Administration (MRA), or Juris Doctor (JD)
• Minimum of five years of previous experience in managing research conflicts of interest
• Minimum two years of experience in conducting GCP monitoring visits of clinical trials.
• Experience in leading a team in the implementation of new software in research administration, especially for the management of research COI.
• Experience developing policies and/or standard operating procedures.
LICENSURE, CERTIFICATION OR REGISTRATION REQUIRED:
• Professional research certification, or other related certification from a professional research organization such as: The Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), Society of Research Administrators International (SRA), Health Care Compliance Association (HCCA), or Public Responsibility in Medicine and Research (PRIM&R)