The Research Protection Program Manager assists the Director, ORP in the oversight of the Research Protection Program (RPP). In this capacity, the RPP Mgr. serves in a leadership role and supervises and mentors ORP IRB and QA staff in order to ensure effective oversight, and coordination of HRPP initiatives. This includes reporting on progress and performance of all HRPP projects, quality of services and compliance with regulatory requirements and education and training. The RPP Manager will assist with planning, development, budget and other administrative activities related to the HRPP.
PRIMARY JOB RESPONSIBILITIES Job responsibilities capture those duties that are essential functions of the job.
Works with Committee Members, Principal Investigators, Research Teams and Clinical Research Management to integrate the RPP across the System.
Responsible for managerial and administrative duties required for direct supervision of ORP HRPP personnel including day-to-day oversight and time management as well as professional growth and development and focal point reviews.
Identifies and responds to issues that prevent full implementation of HRPP initiatives and compliance by research teams and ORP.
Maintains and updates HRPP Standard Operating Procedures (SOPs), and maintenance of policies as directed.
Provides Research Departments with support during external assessments, audits and/or inspections.
Assures the quality and efficiency of IRB review through participation in the review process, ongoing assessment of the IRB life-cycle including the application process, staff review, committee review, correspondence and review timelines and outcomes, current regulations, and policy.
Provides timely assessments concerning Good Clinical Practice needs and specific clinical trial readiness based on results of QA Assessments, including; study start up and first subject reviews, monitor reports and other data.
Promptly reports to the Director, ORP any potential serious or continuing noncompliance or harm to subjects.
Works with the Director to establish the Annual HRPP QA/QI Plan and implements ongoing RPP QA as required by HM policy and Accreditation.
Identifies processes that improve efficiency and efficacy of the HRPP.
Assists with the development of operational tools, resources and capabilities to foster consistency, efficiency, and relationships between internal groups.
Assists the Director in the strategic planning for the departmental mission and participates in Departments future planning and budgeting processes.
Utilizes the results of quality assurance reports and trends to drive a comprehensive educational program.
This job description is not intended to be all inclusive; the employee will also perform other reasonably related business/job duties as assigned. Please see Houston Methodist Career page for additional information.
Master's degree required. Master's degree in in a health science field, strongly preferred.
Certified IRB Professional (CIP) or CIP ready with certification in first year.
Minimum of 5 years of experience including Institutional Review Board. This may include experience in other areas of human research including as: clinical research / coordinator / management / monitor capacity.
A minimum 2 years in IRB leadership position is required.
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human ...disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 277 principal investigators and has more than 840 ongoing clinical trials.