AdventHealthResearch Regulatory Affairs Senior Manager
Orlando, FL

All the benefits and perks you need for you and your family:

  • Benefits from Day One

  • Paid Days Off from Day One

  • Student Loan Repayment Program

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/Days Monday-Friday

Location : 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 Sr. Manager Research Regulatory Affairs is responsible for onboarding new markets in coordination with the Site Support Manager and is knowledgeable in all areas of research regulatory requirements and the multiple different regulatory bodies governing research. The Sr. Manager Research Regulatory Affairs has primary responsibility for the Centralized Research Regulatory team, Research Education & Training team, clinical trial internal monitoring and Research Conflicts of Interest (COI) program, Protocol Review Monitoring System (PRMS) processes and Regulatory Support Services. The Sr. Manager Research Regulatory Affairs will manage the Research Regulatory team who handles all of the IRB and regulatory submissions and processes for all of AdventHealth Research Institute (AHRI) research activities. This position will guide the Research Regulatory team working towards the standardization and streamlining of research regulatory start-up, submission, maintenance, and close-out workflows and processes with a goal of efficiency and compliance. This position has the responsibility to ensure required research training for research compliance and responsible conduct in research is developed and implemented. The Sr. Manager Research Regulatory Affairs will manage the teams by prioritizing and assigning work and ensuring new staff are properly onboarded and trained. The Sr. Manager Research Regulatory Affairs will contribute to the development of the research compliance program and regulatory function and provide input to the Annual Research Risk Assessment and Annual Research Compliance Work Plan. The Research Regulatory Affairs program contributes to the development and implementation of research policies and procedures. The Sr. Manager Research Regulatory Affairs actively participates in outstanding customer service and accepts responsibility in maintaining relationships that are equally respectful to all.

The value you’ll bring to the team:

  • The Sr. Manager is responsible for the daily management of the Centralized Research Regulatory team, Research Education & Training Program, PRMS, Research COI programs, and Regulatory Support team.

  • Supervises direct reports performing a variety of supervisory duties related to the management, performance, evaluations, development conversations, timekeeping, and workflow of the teams reporting to this position.

  • Supervise the work assignments, priorities, and productivity, including the development of training processes and materials of the teams reporting to this position.

  • Provides guidance and mentorship to promote growth for the teams reporting to this position, cultivating a learning, creative, and highly productive work environment.

  • Management duties include overseeing the orientation and training of new staff, communicating priorities, reviewing performance, development, workflow and productivity of the teams.

  • Has accountability and oversight of the development and communication of training and education materials related to research compliance, human subject protection, COI, and research billing as a corporate level function to research investigators, research coordinators, staff and others across multiple states and divisions in the healthcare system.

Qualifications

The expertise and experiences you’ll need to succeed:

  • Bachelor's degree in healthcare, Science, Nursing, Administration, or a research-relatedfield.

  • At least five years’ experience in research regulatory field, working with U.S. Federal research regulations, ICH GCP guidelines, and IRBs in a clinical research setting.

  • Minimum of seven years research experience in a hospital or university.

  • Experience with Investigator Initiated Studies(IIS)

  • Minimum of four years experience in a comparable management position.

  • Minimum of two years of experience in assisting with writing policies, procedures,guidance documents, and/or standard operating procedures inresearch.

  • Minimum of three years experience in managing direct reports.

  • Experience in developing educational presentations and publicspeaking.

  • 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 & Research (PRIM&R).

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

Job Snapshot

  • Facility: AdventHealth Central Florida

  • Job Schedule: Full-time

    Pay Range: $48.69 - $73.03

  • Location: Orlando, FL

  • Job ID: 23038861

  • Job Family: Research

  • Shift: 1 - Day

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