Assistant Director-Human Research Protections Program

Overview

Human Research Protections Program (HRPP) Manager

Position Summary: Baptist Clinical Research Institute is seeking a knowledgeable, respected, goal-driven leader to join our team as a Human Research Protection Program (HRPP) Manager. The successful candidate will have experience in providing administrative oversight to all core components of the institution's HRPP specifically focused on Baptist Memorial Health’s Institutional Review Boards (IRBs) operational needs. The HRPP manager will also be involved in aspects of Training, and Quality Assurance and Improvement. The HRPP Director will oversee the facilitation and support of research reviewed by Baptist Memorial Health’s IRB, including the development and implementation of program goals and objectives.

Specific duties and responsibilities include:                                                      

• Provide integrative coordination and informed input in the planning, development and implementation of the HRPP.
• Establish and implement short-and long-range goals, objectives, policies and operating procedures; monitor and evaluate operational effectiveness and affect changes required for improvement.
• Serve as principal point of collaboration, leadership & expertise to both internal constituencies (e.g., BCRI, BUCOM/BHSU, Privacy Office, Corporate Compliance) and external constituencies on professional and operational matters pertaining to the HRPP.
• Maintain a current knowledge of federal, state, and organizational laws, regulations, policies and guidelines governing human subject research; participate in and provide education and training.
• Interpret and apply federal, state and local regulations, policies and procedures related to research involving human participants.
• Work closely with the Executive Director (BCRI) and the Baptist Memorial Health’s leadership to ensure compliance with the ethical and regulatory requirements for human subjects research.
• Develop & maintain positive relationships with collaborating organizations.
• Act as liaison with federal & state agencies on human research issues.
• Design, implement & evaluate organizational and staffing models to effectively accomplish the goals and objectives of the HRPP.
• Supervise IRB staff.
• Design, develop, implement, evaluate, & modify technical and administrative IRB review processes and internal research auditing policies, protocols, systems, and procedures.
• Work with appropriate internal resources to analyze data and prepare and present IRB audit reports and summaries, and provide feedback to the Institutional Official/Designee, researchers and the IRB as appropriate.
• Identify educational needs of researchers, based on audit data and other information; oversee the development & delivery of targeted training programs and materials based on IRB review and audit results, as well as on changes to legislative, statutory, and/or institutional requirements.
• Provide advice, guidance, and problem resolution to research investigators and support personnel in the application of relevant Federal, State, and institutional laws, regulations, and guidelines.
• Assist with specific inquiries related to scientific misconduct &/or IRB-related non-compliance issues, as requested. 

Job Requirements

Minimum Qualifications: Master's degree; at least 5 years of experience that is directly related to IRB leadership duties and responsibilities specified. And Certified IRB Professional (CIP) or other appropriate certification as a research professional.

OR
 

Bachelor's degree; at least 7 years of experience that is directly related to the duties and responsibilities specified, 3 of which should be in an IRB leadership position. And Certified IRB Professional (CIP) or other appropriate certification as a research professional.

Preferred Qualifications:

• Demonstrated work experience with increasing responsibility in a human subjects protection program. 
• Experience supervising or conducting human research.
• Knowledge of HIPAA regulations and state laws governing privacy.
• Working knowledge of scientific and medical concepts, terminology, and clinical care procedures and standards.
• Working knowledge of good clinical/research practices and standards.