Assistant Director-Human Research Protections Program
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Job Location:
Memphis, TN - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
This position is on-site in Memphis TN
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 institutions HRPP specifically focused on Baptist Memorial Healths 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 Healths 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 Healths 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: Masters 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
Bachelors 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.
Required Experience:
Director
Key Skills
- Nurse Management
- Program Management
- Employee Evaluation
- Management Experience
- Teaching
- Curriculum Development
- Administrative Experience
- Budgeting
- Leadership Experience
- Program Development
- Supervising Experience
- Addiction Counseling
About Company
Baptist Memorial Hospitals provide compassionate, close-to-home care for patients in the Mid-South. Learn about our medical clinics and health care services.
