Regulatory Affairs Professionals Society
Director of Research Compliance
Regulatory Affairs Professionals Society, Pasadena, California, United States, 91122
Director of Research Compliance
Caltech
Job Category:
Fulltime RegularExempt Overtime Eligible:
ExemptBenefits Eligible:
Benefit Based
Caltech is a world-renowned science and engineering institute that marshals some of the world's brightest minds and most innovative tools to address fundamental scientific questions. We thrive on finding and cultivating talented people who are passionate about what they do. Join us and be a part of the diverse Caltech community.
Job Summary
Serving under the Associate Vice Provost for Research Policy and Compliance, directs the Research Compliance Program of the Institute to enable research at Caltech to be conducted in accordance with the highest standards of integrity in adherence and compliance with all federal, state, local, and Institute regulations. The Director shall provide management oversight to the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), the Human Embryo and Stem Cell Committee (HESC), the Radiation Safety Committee (RSC), the Institute's Controlled Substances Program, and required training for researchers. They shall ensure Institute compliance with U.S. federal, California state, and local regulations governing the research overseen by these committees and other regulated research. They will also coordinate with the Associate Vice Provost for Research Policy and Compliance to maintain a robust, responsible conduct of research and research integrity program.
Essential Job Duties
Directs, guides, and oversees the activities of the Institute research regulatory committees (IRB, IBC, IACUC, HESC, RSC), the Institute Controlled Substances Program, and the related Institute research training programs to ensure compliance with federal, state, and local regulatory requirements.Supervises the IACUC, IRB/HESC, and IBC/RSC/Research Training Research Compliance Administrators.Coordinates with the Associate Vice Provost for Research Policy and Compliance to develop, modify, and implement Institutional policies and procedures along with strategic plans and objectives that have Institute-wide impact over Research Compliance.Guides and provides strategic direction and support to the Institutional Official for the research committees and aids in the preparation of reports to oversight agencies, renewals of assurances, and communications with accrediting organizations, as required.Oversees implementation of the electronic-based record system for Institute research regulatory committees and training records, with the aim of coordinating committee transparency and emphasis on inter-committee communication.In coordination with the Associate Vice Provost for Research Policy and Compliance, works with the Offices of Sponsored Research, Environmental Health & Safety (EHS), Research Security, General Counsel, and other Institutional stakeholders to ensure compliance with current regulations regarding research with human participants, animals, recombinant and synthetic nucleic acids, radiation, and controlled substances.In coordination with the Associate Vice Provost for Research Policy and Compliance, establishes, communicates, and oversees an Institutional research training program; coordinates or conducts workshops and seminars regarding research with human participants, animals, recombinant and synthetic nucleic acids, radiation, controlled substances, as well as responsible conduct of research and research integrity.Responsible for providing broad direction and coordinating research regulatory activities on campus to ensure consistency and enable compliant research.Responsible for decisions on hiring, promotions, salary changes, training, and performance evaluations of subordinate staff.
Basic Qualifications
Bachelor's degree.At least 8 years of relevant experience in a scientific, federal-funded organization.Advanced level of understanding of operational requirements related to the management and implementation of an IRB, IACUC, IBC, and HESC in a university setting.Advanced level of knowledge regarding U.S. federal and California state research regulations, including knowledge of such regulations as applicable to use of human or animal subjects, use of recombinant DNA, use of embryos and stem cells in research, and responsible conduct of research.Excellent verbal and written communication skills and the ability to effectively communicate with persons at all levels of the Institute.Advanced level of organizational skills and independent decision-making ability.Effective team player with the ability to work well with people.Ability to handle confidential matters with discretion and exercise good judgment.Ability to supervise staff.
Preferred Qualifications
Advanced degree.
Required Documents
ResumeCover Letter
To be considered for this position please visit our web site and apply on line at the following link:
https://hr.caltech.edu/work/job_openings
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
#J-18808-Ljbffr
Caltech
Job Category:
Fulltime RegularExempt Overtime Eligible:
ExemptBenefits Eligible:
Benefit Based
Caltech is a world-renowned science and engineering institute that marshals some of the world's brightest minds and most innovative tools to address fundamental scientific questions. We thrive on finding and cultivating talented people who are passionate about what they do. Join us and be a part of the diverse Caltech community.
Job Summary
Serving under the Associate Vice Provost for Research Policy and Compliance, directs the Research Compliance Program of the Institute to enable research at Caltech to be conducted in accordance with the highest standards of integrity in adherence and compliance with all federal, state, local, and Institute regulations. The Director shall provide management oversight to the Institutional Review Board (IRB), Institutional Animal Care and Use Committee (IACUC), Institutional Biosafety Committee (IBC), the Human Embryo and Stem Cell Committee (HESC), the Radiation Safety Committee (RSC), the Institute's Controlled Substances Program, and required training for researchers. They shall ensure Institute compliance with U.S. federal, California state, and local regulations governing the research overseen by these committees and other regulated research. They will also coordinate with the Associate Vice Provost for Research Policy and Compliance to maintain a robust, responsible conduct of research and research integrity program.
Essential Job Duties
Directs, guides, and oversees the activities of the Institute research regulatory committees (IRB, IBC, IACUC, HESC, RSC), the Institute Controlled Substances Program, and the related Institute research training programs to ensure compliance with federal, state, and local regulatory requirements.Supervises the IACUC, IRB/HESC, and IBC/RSC/Research Training Research Compliance Administrators.Coordinates with the Associate Vice Provost for Research Policy and Compliance to develop, modify, and implement Institutional policies and procedures along with strategic plans and objectives that have Institute-wide impact over Research Compliance.Guides and provides strategic direction and support to the Institutional Official for the research committees and aids in the preparation of reports to oversight agencies, renewals of assurances, and communications with accrediting organizations, as required.Oversees implementation of the electronic-based record system for Institute research regulatory committees and training records, with the aim of coordinating committee transparency and emphasis on inter-committee communication.In coordination with the Associate Vice Provost for Research Policy and Compliance, works with the Offices of Sponsored Research, Environmental Health & Safety (EHS), Research Security, General Counsel, and other Institutional stakeholders to ensure compliance with current regulations regarding research with human participants, animals, recombinant and synthetic nucleic acids, radiation, and controlled substances.In coordination with the Associate Vice Provost for Research Policy and Compliance, establishes, communicates, and oversees an Institutional research training program; coordinates or conducts workshops and seminars regarding research with human participants, animals, recombinant and synthetic nucleic acids, radiation, controlled substances, as well as responsible conduct of research and research integrity.Responsible for providing broad direction and coordinating research regulatory activities on campus to ensure consistency and enable compliant research.Responsible for decisions on hiring, promotions, salary changes, training, and performance evaluations of subordinate staff.
Basic Qualifications
Bachelor's degree.At least 8 years of relevant experience in a scientific, federal-funded organization.Advanced level of understanding of operational requirements related to the management and implementation of an IRB, IACUC, IBC, and HESC in a university setting.Advanced level of knowledge regarding U.S. federal and California state research regulations, including knowledge of such regulations as applicable to use of human or animal subjects, use of recombinant DNA, use of embryos and stem cells in research, and responsible conduct of research.Excellent verbal and written communication skills and the ability to effectively communicate with persons at all levels of the Institute.Advanced level of organizational skills and independent decision-making ability.Effective team player with the ability to work well with people.Ability to handle confidential matters with discretion and exercise good judgment.Ability to supervise staff.
Preferred Qualifications
Advanced degree.
Required Documents
ResumeCover Letter
To be considered for this position please visit our web site and apply on line at the following link:
https://hr.caltech.edu/work/job_openings
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
#J-18808-Ljbffr