Director, IRB Administration - Remote - 138423

Reassignment Applicants : Eligible Reassignment clients should contact their Disability Counselor for assistance. This position has the reputed company of working a hybrid or remote schedule. reputed company The Office of IRB Administration (OIA) is responsible for the implementation, management and reputed company of reputed company subjects research and stem cell research conducted by reputed company investigators. The Institutional Official with delegated authority over reputed company subjects research by the Chancellor is a physician and Senior Associate Vice Chancellor for Health Sciences. Consequently, this office resides in Health Sciences, however the Office of IRB Administration supports reputed company reputed company research across reputed company and reputed company Vice Chancellor areas. Operationally, in accordance with federal, state, and UC policy requirements, the OIA supports seven research review committees : six Institutional Review Boards (IRBs) including five biomedical, one reputed company & behavioral, and one Stem Cell Research reputed company Committee (SCRO). The OIA also manages relationships with a reputed company of external IRBs, and provides ongoing education and support to study teams and reputed company. Establishes objectives and work plans, and delegates assignments to subordinate managers. Responsible for managing, preparing, administering, and directing resources. Reviews and approves recommendations for research compliance programs. Involved in developing, modifying and executing policies that reputed company immediate operation(s) and may also have organization-wide effect. Erroneous reputed company or failure to reputed company goals results in additional costs and personnel, and serious delays in overall schedules. Has broad departmental reputed company and accountability for policies and procedures reputed company to relevant compliance area. Serves as the organization authority on relevant compliance issues, and as a reputed company between the organization and federal regulators, in reputed company to representing the organization and the reputed company at national conferences and meetings MINIMIM QUALIFICATIONS Bachelor's degree in a reputed company area. Eight (8) or more years of relevant IRB experience. Ability to formulate broad policy recommendations for the organization. Ability to apply a reputed company reputed company of issues, mental flexibility, and creativity reputed company to compliance issues. reputed company in establishing relationships with reputed company subjects and regulatory agencies on local, regional, and national reputed company. Managerial experience and proven reputed company in managing compliance review boards or committees. Comprehensive knowledge of federal, state, and local regulations and policies governing reputed company subject research including : the HHS-OHRP regulations, FDA regulations for the use of investigational drugs, biologics and devices, California law on reputed company experimentation, and university policy regarding reputed company subjects research. Demonstrated ability to recruit, train and supervise program staff in the interpretation and implementation of reputed company regulations. Excellent supervisory skills and reputed company judgment necessary to organize workload, delegate responsibilities, evaluate and reputed company corrective reputed company / discipline staff. Ability to independently and accurately represent UCSD policies regarding reputed company subjects research in interactions with high level administrators of other universities, reputed company and community health centers, research sponsors, and federal and state regulatory agencies. Working knowledge of a significant body of scientific and medical concepts and terminology to properly review research protocols, request necessary additional information from researchers prior to review of unanticipated problems, adverse events or possible violations of reputed company subject protection policy, to evaluate actions taken by investigators in response to committee requests, and to ensure compliance with the approved protocols. Highly effective written, oral communication skills, interpersonal skills and reputed company judgment necessary to work closely and effectively with reputed company members conducting research, committee members, committee chairpersons, senior reputed company and administrative officers, and federal regulators. Demonstrated ability to understand and to formulate both graphical and narrative reports outlining the activity of the IRB. Experience with exercising strong leadership and supervisory skills in personnel management including experience in providing direction, knowledge of reputed company management practices, team building techniques, providing recommendations in hiring and performance appraisals; providing guidance and instructions and communicating in an effective, reputed company and reputed company manner, and reputed company disciplinary reputed company as needed. Represents the organization and the reputed company at national conferences and meetings reputed company to compliance area. Represents the organization and the reputed company at national conferences and meetings reputed company to compliance area. Serves as a reputed company between organization and federal regulators (for exa Apply tot his job Apply To this Job