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Baptist Memorial Health Care · 4 months ago

Assistant Director-Human Research Protections Program

350 North Humphreys Boulevard, Memphis, TN, 38120, US

Full-time

Onsite

Lead/Staff, Director/Executive

5+ years exp

Baptist Memorial Health Care is seeking a knowledgeable leader to join their team as a Human Research Protection Program (HRPP) Manager. This role involves providing administrative oversight to the institution's HRPP, focusing on operational needs of the Institutional Review Boards (IRBs), and ensuring compliance with ethical and regulatory requirements for human subjects research.

GovernmentHealth CareHospitalMedicalNon ProfitNursing and Residential CareRehabilitationWellness

Responsibilities

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

Qualification

IRB leadership experienceCertified IRB Professional (CIP)Human subjects protection programHIPAA regulations knowledgeClinical practices knowledgeTrainingEducation skillsProblem resolution skillsCollaboration skills

Required

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

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