IACUC / Safety Analyst - Military Veterans
at Houston Methodist
At Houston Methodist, the Research Protections, Pre-Clinical Regulatory Analyst position is responsible for the comprehensive analysis of pre-clinical research protocols, and associated submissions for completeness, consistency, and compliance with regulations, guidelines, and institutional policies. In preparation for Institutional Animal Care and Use Committee (IACUC), Hazardous Substance Committee (HSC), Institutional Biosafety Committee (IBC), and Radiation Safety Committee (RSC) designee or committee review, gather additional data as necessary from researchers, study staff, and others. This position provides appropriate guidance to researchers and committee members to ensure the protection of subjects in research, patients, and the environment; Using the regulations and institutional policies as a guide, the Research Protections, Pre-Clinical Regulatory Analyst position advises investigators and study teams of potential gaps in protocol submissions, including associated documents, and suggests solutions to facilitate research. In collaboration with Research Protections, Sr. Regulatory Analysts, and the Office of Research Protections (ORP) leadership, this position advises and provides input to Research Protections, Regulatory Coordinators, and other research stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes. As needed, the Research Protections, Pre-Clinical Regulatory Analyst position provides support to Research Protections, Sr. Regulatory Analysts and ORP leadership in the management of the HM Business Practice Committee and Conflict of Interest reviews.
PRIMARY JOB RESPONSIBILITIES
Job responsibilities labeled EF capture those duties that are essential functions of the job.
PEOPLE - 20%
- Advises and provides input to Principle Investigators (PI) and other research stakeholders on the interpretation of regulations and guidance from oversight authorities, compliance matters, and institutional processes in review/preparation of protocol submissions for committee consideration. (EF)
- Clearly and efficiently communicates with research stakeholders including investigators, study teams, committee members, and ORP colleagues, in review/preparation of protocol submissions for committee consideration. (EF)
- Conducts self in a manner that is congruent with cultural diversity, equity, and inclusion principles. Contributes towards improvement of department scores for employee engagement, i.e., peer-to-peer accountability. (EF)
SERVICE - 20%
- Prepares committee meeting agendas. Assists Committee Chairs and other ORP team members in management of committee meetings, including providing guidance to the members on regulatory requirements. (EF)
- Prepares and reviews meeting minutes and meeting correspondence, ensuring regulatory requirements, committee determinations and controverted issues (when applicable) are accurately captured and documented accordingly. Assists in preparation and review of official committee correspondence after committee reviews are complete. (EF)
- Creates educational and training materials for Research Protections training, committee member education, and Open House sessions. (EF)
QUALITY/SAFETY - 40%
- Coordinates all aspects of research proposal submission, review, and approval processes, and assures reviews are commensurate with applicable regulatory regulations and institutional policies. Conducts reviews of research applications, and associated documents, to ensure completeness, consistency, and accuracy in preparation for committee review. (EF)
- Makes regulatory recommendations to drive required ancillary committee and regulatory committee reviews. Prepares succinct synopsis for all protocol submissions, highlighting any regulatory considerations or determinations the committee must include in its review. (EF)
- Assists in the development of Office of Research Protection (ORP) processes and workflows, to support regulatory and institutional requirements. (EF)
- Assists ORP management in the planning, implementation, and follow-up of all regulatory and accreditation requirements. (EF)
FINANCE - 5%
- Utilizes resources with cost effectiveness and value creation in mind. Self-motivated to independently manage time effectively and prioritize daily tasks, assisting coworkers as needed. (EF)
GROWTH/INNOVATION - 15%
- Identifies areas of the ORP/Committee review processes that require improvement or streamlining in order to facilitate research. (EF)
- Works in the electronic research administration platform(s) to ensure all appropriate regulatory correspondence is captured. Suggests improvements to the research administration platform(s) to ensure compliance, test programming upgrades. (EF)
- Assists in research protection (re)accreditation processes. (EF)
- Seeks opportunities to identify self-development needs and takes appropriate action. Ensures own career discussions occur with appropriate management. Completes and updates the My Development Plan on an on-going basis. (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.
o Bachelor’s degree in related field or Master’s degree in Research Administration, Legal, Ethics, Policy, Sciences, or related field
o Two years of research experience within an IACUC or IBC or RSC Research Protections Program or two years of direct regulatory oversight of research with a Bachelor’s degree OR one year of experience within an IACUC or IBC or RSC Research Protections Program or one year of direct regulatory oversight of l research with a Master’s degree
CERTIFICATIONS, LICENSES AND REGISTRATIONS REQUIRED
o Certified Professional IACUC Administrator (CPIA) within one year of eligibility to sit for the CPIA exam
o Other research certificates encouraged
KNOWLEDGE, SKILLS AND ABILITIES REQUIRED
o Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
o 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 patient or employee safety or security
o Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
o Must have ability to rapidly acquire and implement knowledge of related regulations and ethical principles
o Exercises independent judgment related to situations of a sensitive, confidential, and scientific nature
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 Yes
Houston Metropolitan area
May require travel outside Yes
of Houston Metropolitan area
**Travel specifications may vary by department.
Please note any other special considerations to this job: __________________________
Houston Methodist Academic Institute was formed to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies and treatments. The Research Institute was created in 2004 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 and clinical trials, the Academic Institute houses over 2,110 credentialed researchers conducting 1,387 ongoing clinical protocols.
At Houston Methodist, Leading Medicine is more than a description of what we do; it's who we are. We take our responsibility as Houston's premier health care system seriously, and with a national reputation for excellence in patient care, innovation and research, we hold ourselves and the careers we build to a higher standard. Our culture is diverse, dynamic and challenging. We believe in our I Care Values and conduct ourselves with Integrity, Compassion, Accountability, Respect for others and a commitment to Excellence. Discover the difference for yourself and join Houston Methodist.
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