Associate Director, Office of Research Protections
Houston Methodist Research Institute
June 13, 2018
Full Time - Experienced
CCRC (Certified Clinical Research Coordinator), CPI (Certified Principal Investigator), CCRP (Certified Clinical Research Professional)
The Associate Director for the Office of Research Protections (ORP) ensures effective oversight, and compliance with federal and institutional regulatory and ethical requirements related to human subject research conducted under the auspices of Houston Methodist. This position will manage all functions of the (IRB) for Houston Methodist. Additionally, the Associate Director will support the ORP Quality Assurance (QA) Program related to human subject research.
PATIENT AGE GROUP SERVED
DUTIES AND RESPONSIBILITIES
PEOPLE - 20%
Responsible for managerial and administrative duties required for direct supervision of IRB and QA personnel including day-to-day oversight and time management as well as professional growth and development and focal point reviews. (EF)
Works with Committee Members, Principal Investigators, Research Teams and Clinical Research Management to integrate the HRPP across the System. (EF)
Identifies and responds to issues that prevent full implementation of HRPP initiatives and compliance by research teams and ORP.
SERVICE - 20%
Maintains and updates HRPP Standard Operating Procedures (SOPs), and maintenance of policies as directed. (EF)
Participates in HM Committees and/or other system initiatives related to clinical research.
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. (EF)
Provides support to assure timely assessments concerning Good Clinical Practice needs and specific clinical trial readiness based on results of QA Assessments. (EF)
Promptly reports to the Director, ORP any potential serious or continuing noncompliance or harm to subjects. (EF)
Works with the Director to establish the Annual HRPP QA/ QI Plan and implements ongoing HRPP QA as required by HM policy and Accreditation. (EF)
FINANCE - 20%
Assures appropriate use of departmental resources; (EF)
Identifies processes that improve efficiency and efficacy of the HRPP.
GROWTH/INNOVATION - 20%
Assists with the development of operational tools, resources and capabilities to foster consistency, efficiency, and relationships between internal groups. (EF)
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 continually improve compliance and quality.
This job description is not intended to be all inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
Bachelor’s degree required. Master’s degree in in a health science field, preferred.
Minimum of 5 years of experience in Institutional Review Board. A minimum of 2 years in an IRB leadership position is required.
CERTIFICATES, LICENSES AND REGISTRATIONS REQUIRED
Certified IRB Professional (CIP) or CIP ready with certification in first year
SPECIAL KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations.
Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting protocol review, assessment and documentation.
Ability to effectively communicate with physicians, members of the research team and co-workers in a manner consistent with a customer service focus and application of positive language principles.
Internal Number: 38235
About Houston Methodist Research Institute
Houston Methodist comprises a leading academic medical center in the Texas Medical Center and six community hospitals serving the Greater Houston area. Each hospital is staffed by committed personnel who exemplify our I CARE values: integrity, compassion, accountability, respect and excellence. Patient safety, quality and service are our highest priorities.
Houston Methodist Hospital, the system's flagship, is consistently listed among U.S. News & World Report's best hospitals, and we extend that same level of quality care across the system. Other available centers include Houston Methodist Emergency Care Centers, the Houston Methodist Imaging Center, the Houston Methodist Breast Care Center and the Houston Methodist Outpatient Center.