At Houston Methodist, the Director of Research Protection position is responsible for ensuring that research proposed and/or conducted at or under the oversight of Houston Methodist Research Institute, (HMRI) is done in accordance with federal and institution regulatory requirements. Research oversight includes human, animal, recombinant DNA, non-recombinant DNA, and radiation use. In addition, the Director of the Office of Research Protection (ORP) manages the HMRI Business Practices Committee, the Conflict of Interest review and management process, and the Office of Research Integrity. The director serves in a leadership role and provides strategic oversight of department processes. This role establishes and implements short-and long-range organizational goals objectives, policies, and operating procedures; monitors and evaluates operational effectiveness; and effects changes required for improvement.
The Director position responsibilities include overseeing the activities of the department staff, ensuring quality, productivity, functional excellence and efficiency to accomplish strategic and operational objectives. In addition, this position is accountable for employee engagement, adequate staffing levels, budget development and compliance, staffing decisions such as hiring and terminating employment, coaching and counseling employees on work related performance, and developing and implementing policies and procedures to ensure a safe and effective work environment. This position also ensures training, monitoring and operations initiatives are implemented which secure compliance with ethical and legal business practices and accreditation/regulatory/government regulations.
PATIENT AGE GROUP(S) AND POPULATION(S) SERVED
Refer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.
HOUSTON METHODIST EXPERIENCE EXPECTATIONS
Provide personalized care and service by consistently demonstrating our I CARE values:
INTEGRITY:We are honest and ethical in all we say and do.
COMPASSION:We embrace the whole person including emotional, ethical, physical, and spiritual needs.
ACCOUNTABILITY:We hold ourselves accountable for all our actions.
RESPECT:We treat every individual as a person of worth, dignity, and value.
EXCELLENCE:We strive to be the best at what we do and a model for others to emulate.
Focuses on patient/customer safety
Delivers personalized service using HM Service Standards
Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)
Intentionally rounds with patients/customers to ensure their needs are being met
Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job
PRIMARY JOB RESPONSIBILITIES
Job responsibilities labeled EF capture those duties that are essential functions of the job.
Directs, develops and implements strategic and operational/high level projects and processes either through independent/highly autonomous work or through the facilitation of work teams to enable the effective and efficient completion of objectives. (EF)
Oversees management of and ensures development for staff to meet overall objectives in terms of quality, service and cost effectiveness. Provides timely guidance and feedback to help others strengthen specific knowledge/skill areas needed to accomplish a task or solve a problem. Directs management responsibilities of selection, scheduling, supervision, retention, and evaluation of employees. (EF)
Meets or exceeds threshold goal for department turnover and/or system metrics on employee engagement indicators: action readiness score, tier level. (EF)
Provides leadership and communication to maintain a competent and engaged employee group by conducting regular department meetings to review policies and procedures and operational matters, rounding on all employees, completing performance appraisals, conducting new hire feedback sessions, coaching/corrective counseling, and providing recognition/commendations to achieve desired outcomes. (EF)
Identifies opportunities and takes action to build strategic relationships between one’s area and other areas, teams, departments, and units to achieve business goals. Drives the promotion of teamwork within and between departments; participates and/or leads and facilitates department process improvements as needed. (EF)
Provides direction to regulatory committee members, research staff members, research staff members and other departments involved in the regulatory review process, making amendments/adjustment to policies and procedures as dictated by emerging issues. (EF)
Oversees department operations, designated projects, schedules and activities as needed to ensure that goals or objectives are accomplished within the prescribed time frame. Sets priorities and functional standards, giving direction to staff as necessary to ensure the best possible delivery of service and high customer/patient satisfaction. (EF)
Drives department service standards and activities to impact department and/or system score for patient/customer-based satisfaction, through role modeling and fostering accountability. Serves and actively participates on various entity committees as a voice for the department. (EF)
Provides strategic oversight of:
Institutional Review Board (IRB)
Institutional Animal Care and Use Committee (IACUC)
Hazardous Substances Committee (HSC)
Institutional Biosafety Committee (IBC)
Radiation Safety Committee (RSC)
Business Practice Committee
Serve as Human Protections Administrator for Houston Methodist Hospital, (HMH), establishing relationships with the various government regulatory agencies and serving as point of contact for all research on human subjects conducted at Houston Methodist Hospital. (EF)
Ensures a safe and effective working environment; monitors and/or revises the department safety plan and/or any specific accreditation/regulatory required safety guidelines. Responsible for staff maintenance of credentials and competencies, per accrediting/ licensing agency and/or department guidelines as applicable. (EF)
Employs a proactive approach in the optimization of safe outcomes and information systems by monitoring and improving the department workflow and enhancing operations, using peer-to-peer accountability and identifying solutions via collaboration. Implements process improvements utilizing tools such as lean principles. Role models situational awareness, using teachable moments to improve safety. (EF)
Responsible for employee compliance to policies and procedures and performs associated actions upon non-compliance (i.e., licensure/certification compliance, focal point review requirements, disaster plan, in-services, influenza immunization, wage and hour, standard hours, timely termination submission, timely timecard approval, etc.). (EF)
Establishes, reviews, and updates policies and procedures to support the complete life cycle of the regulatory review process (IRB, IACUC, HSC, IBC, RSC, and COI) (EF).
Conducts, or assures, a thorough review of research protocols prior to submission to the regulatory committees for review. Provides comments to the applicable regulatory committees for consideration with submissions to assure that the review is conducted according to regulations and guidance. (EF)
Facilitates the inspection of regulatory committee activity records and on-site research facilities by regulatory agencies during investigations and audits. (EF)
Develops and provides a variety of training programs for researchers and research staff. Works win concert with other HMRI Administrator directors, to provide programs that address key compliance areas, such as Good Clinical Practice (GCP), Conflicts of Interest (COI), and Responsible conduct of Research (RCR).
FINANCE -10 %
Develops and manages department operational and capital budgets, approvals, and ongoing maintenance of the department(s), ensuring operation in a cost-effective manner. Proactively identifies and plans for capital needs related to current equipment and future department projects. Ensures staffing plans and schedules meet department needs that reflect understanding of the importance of cost-effectiveness. (EF)
Creates department strategies to achieve financial target and staffing needs, through optimizing productivity, supply/resource efficiency, minimizing incidental overtime and overtime percentage, and other areas according to department specifications. (EF)
Provides strategic oversight and oversees the administration of the HMRI Conflict of Interest program, including the disclosure process and implementation of management action plans. (EF)
Identifies and implements innovative solutions for practice or workflow changes to improve department, entity or system operations by leading unit projects and/or other department/ system-directed activities. Proactively leads task forces and committees. May represent HM at assigned community or professional organization meetings. (EF)
Drives change initiatives, maintaining effectiveness when experiencing major changes in work responsibilities or environment; adjusts effectively to work within new work structures, processes, requirements or cultures. Partners effectively with stakeholders as appropriate. (EF)
Ensures own career discussions occur with appropriate management. Completes and updates the individual development plan (IDP) on an on-going basis. Conducts conversations with staff on their development and IDP. (EF)
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.
Master’s degree in Health Care, Biological Sciences, or related field, required
Ten years’ experience in a related research setting required with five years’s progressive experince managing professional/technical/clinical staff.
CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED
IRB Professional certification (CIP) required
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 about activities impacting patient or employee safety or security
Demonstrates the ability to interact with others in a way that gives them confidence in one’s intentions and those of the organization
Ability to use appropriate interpersonal styles and techniques to gain acceptance of ideas or plans; modifying one’s own behavior to accommodate tasks, situations and individuals involved
Demonstrates leadership qualities and critical thinking through self-direction initiative and effective interpersonal skills and oral/written communication skills
Ability to identify and understand issues, problems and opportunities, comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints and probable consequences
Extensive knowledge of regulatory and accreditation agency requirements that impact department; stays abreast of industry changes
Demonstrates highly effective communication skills—strong written communications and platform presentation abilities
Ability to work effectively in a fast-paced environment
Demonstrates flexibility and adaptability in the workplace
Capable of leading teams/facilitating groups, building consensus and garnering highest confidence in professionalism and work product by senior leadership
Ability to work under pressure and balance many competing priorities; highly responsive and solution/action oriented
Proficiency in spreadsheet, word processing, and presentation software
Maintains a positive and supportive attitude and demeanor
Professional handling of exposure to confidential/sensitive information
Demonstrates knowledge in IRB, IACUC administration, Conflict of Interest Management, and Research Integrity
Work Attire Yes/No
Business professional Yes
Other (dept approved) No
*Note that employees may be required to be on-call during emergencies (i.e. Disaster, Severe Weather Event, etc.) regardless of selection above.
May require travel within No
Houston Metropolitan area
May require travel outside No
of Houston Metropolitan area
**Travel specifications may vary by department.
Internal Number: 59978
About Houston Methodist Research Institute
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.