Presbyterian Healthcare Services · 5 days ago
Manager - Human Research Protection Office
Presbyterian Hospital
Full-time
Onsite
Mid Level
$72K/yr - $110K/yr
3+ years expPresbyterian Healthcare Services is a not-for-profit healthcare system dedicated to improving the health of communities. They are seeking a Manager for the Human Research Protection Office who will promote and manage the functions of the IRB operation, ensuring compliance and oversight of research studies.
AssociationHealth Care
Responsibilities
Developing, implementing, and managing efficient procedures to facilitate the processing of human subject research protocol in accordance with institutional, State, Federal, and possibly accreditation bodies policies and procedures
Planning and coordinating IRB review and follow-up activities
Serving as an expert liaison between the research investigator and the reviewer; education parties on relevant and emerging regulations and related risk management issues
Performing review of complex research protocols, including identifying problems and issues in the submission application, and contacting the investigator to request additional materials
Aiding the Presbyterian Human Research Protection Program (HRPP/Clinical Research) leadership in preparation for audits and possible accreditation and in various compliance and quality assurance activities
Protocol Evaluation and management: Review and evaluate research protocols, modifications, continuing reviews, and event reports for approval based on applicable research laws, regulations, and guidelines. Correspond with researchers to ensure applications are clear and complete. Ensure the IRB staff is processing all submissions in a timely manner in order to meet deadlines and workflow standards
Knowledge on the use of electronic submission platforms and data management systems. Use electronic submission and data management systems with accuracy to track submissions and retain documentation in accordance with policy and regulation
Develop and maintain good working relationship with members of the research community
Review of current program processes for workflow and effectiveness optimization
Qualification
Required
Master of Science degree and three years of relevant experience, or combination of education and relevant experience
Three years of experience in clinical research required
Comprehensive knowledge of regulatory information regarding the use of human/animal participation in research and teaching
Demonstrated understanding of the principles of human/animal research protection standards
Strong knowledge of grants and contracts functions
Significant working knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management
In-depth understanding of operational requirements pertaining to management and implementation of protocol process
Demonstrated strong verbal and written communication skills
Knowledge of human/animal subject federal and state laws and guidelines
Benefits
Medical
Dental
Vision
Short-term and long-term disability
Group term life insurance
Other optional voluntary benefits
Presbyterian's Employee Wellness rewards program
Company
Presbyterian Healthcare Services
Presbyterian Healthcare Services exists to improve the health of patients, members and the communities they serve.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Dale Maxwell
President and CEO
Ernest Sanchez
Chief Technology Officer
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