BSS Human Research Protection Program Analyst Part Time

Banner Health•Phoenix, AZ

8d•Remote

About The Position

This position supports Banner Health (BH) Human Research Protection Program (HRPP) management and staff and assists in the management of the BH Institutional Review Board (IRB) and Research Determination Committee (RDC). This includes a critical role in providing technical assistance for management of the BH IRB & RDC and a pivotal role in monitoring compliance with and follow-up of annual research staff reporting requirements; assisting the BH Research Regulatory Affairs team, assisting in the development and implementation of training documents and policy & procedures; assisting with the day-to-day operations and maintaining tracking systems for the department.

Requirements

Must possess relevant knowledge as typically obtained through the completion of a bachelor’s degree in clinical research, compliance or other health-related field and at least two years of relevant work experience.
Must demonstrate a strong understanding of regulatory affairs, IRB management and/or clinical research coordination/operations with experience work for/with an HRPP and/or IRB in regulatory affairs for clinical research or clinical research coordination/operations.
Ability to effectively and professionally communicate both verbally and in writing with research stakeholders, including physicians.
Must have excellent organizational and task management skills allowing the individual to efficiently multi-task and prioritize workload in a fast-paced environment.
Familiarity with IRB, research compliance and regulations.

Nice To Haves

Additional related education and/or experience preferred.

Responsibilities

Maintains knowledge of current IRB and HIPAA research regulations and Banner policies. Under supervision of HRPP and IRB leadership, analyzes, interprets and applies all applicable regulations, Banner Health policies and ethical principles governing human subject research for program impacts.
Assists IRB leadership with oversight and management of the daily operations of the IRB office. Serves as liaison between the IRB and RDC and the research team. Provides in-person and phone consultation to Banner research staff concerning preparation and submission of IRB and RDC applications. Works with investigators and research staff to ensure that requested modifications to the application or other application material are completed.
Supports IRB leadership in management of the full IRB/RDC review process during meetings, including preparation of meeting agenda and minutes. Drafts and sends correspondence that conveys IRB/RDC deliberations and contingencies for approval.
Coordinates the orientation, education and training of board members. Trains new research staff on the IRB electronic submission system. Ensures research staff and IRB members understand compliance obligations by overseeing development and dissemination of guidance through effective education and outreach methods.
Assists with Association for the Accreditation of Human Research Protection Program accreditation processes.
Develops and updates documents, written materials and procedures for various assigned projects; including, but not limited to, annual conflict of interest (COI) disclosure, IRB Authorization Agreements, policy, guidance and standard operating procedures (SOP) documents and IRB & RDC submissions and meetings.
Coordinates the collection of information necessary to assure compliance with annual reporting requirements. Provides necessary follow-up efforts, such as emails and phone calls, to assure timely completion. Provides leadership with reports and/or spreadsheets reflecting non-compliance with the reporting requirements.
Creates, updates and maintains relevant centralized tracking mechanisms for assigned projects as needed. Assures the accuracy of any regulatory documents received as well as ensuring all appropriate institutional signatures are obtained as required.
Provides support, guidance and coordination for HRPP project management and implementation across the organization, region and/or facility/entity. Customers include all staff levels within the organization, as well as external customers.