A cover letter is required for consideration for this position and should be attached as the first page of your resume. The cover letter should address your specific interest in the position and outline skills and experience that directly relate to this position.
The University of Michigan (U-M) Environment, Health & Safety (EHS) department seeks a highly responsible and skilled individual to administer its Radioactive Drug Research Committee/Subcommittee on Human Use of Radioisotopes (RDRC/SHUR). The RDRC/SHUR is a subcommittee of the U-M Radiation Policy Committee, responsible for the review of research studies involving the human use of radioactive materials, in coordination with the U-M Medical School Institutional Review Board (IRB). The RDRC/SHUR Committee Administrator will report to the Director, Radiation Safety Service (EHS), with dotted line accountability to the Medical School Director of Regulatory Affairs.
***This is a four-year limited term, benefits eligible position with potential for renewal***
Key responsibilities include, but are not limited to, the following:
Develop and maintain expertise in institutional policy, governmental regulations, professional standards, and other content regarding RDRC/SHUR issues and matters
Provide expertise, insight, vision, and leadership, and exercise independent judgment, in administering the RDRC/SHUR committee and program to ensure that:
Appropriate institutional policies, systems, procedures, and practices are developed, reviewed, maintained, implemented, and sustained
Faculty and staff are aware and reminded of their RDRC/SHUR obligations
Unfulfilled obligations are pursued until resolved
Guidance is provided and questions answered
The RDRC/SHUR committee is appropriately supported
Records and metrics are maintained and reported in accordance with institutional expectations, professional standards, and governmental requirements
Compliance with institutional policy, governmental regulations, and professional standards is achieved
Process submissions to the RDRC/SHUR, including:
Track incoming submissions
Verify and release submissions not requiring review
Pre-review submissions requiring review in order to proactively resolve problematic issues
Distribute submissions to reviewers and assist as requested
Compile, document, and return reviewer comments to submitter
Track submitter responses and forward to reviewers
Track committee votes and release submission approvals as appropriate
Administer the RDRC/SHUR committee, including:
Develop agendas and discussion materials
Track precedents and action items
Maintain records and prepare documents and reports, including RDRC annual report to FDA
Correspond on behalf of committee
Provide senior staff level vision, expertise, and support to the RDRC/SHUR committee chair and members, and to the RSO and UMMS Director of Regulatory Affairs, as appropriate
Apply broad understanding of relevant principles, practices, procedures to completion of difficult assignments, trouble-shooting, and analysis, comparison, and evaluation of different courses of problem-solving actions
Perform data entry and complex analyses to enable reporting, recommendations, and decisions
Develop educational materials and exhibit high level professionalism, knowledge, and skill in presenting RDRC/SHUR issues and advice to institutional leaders and faculty
Apply insight, judgment, and diplomacy in assessing and advising faculty on non-routine RDRC/SHUR matters, including proposal and follow-up of corrective and preventive action (CAPA) plans as appropriate
Network and collaborate with internal and external colleagues and stakeholders, including service on relevant institutional committees/units (eResearch, etc.) and participation/presentation at national forums as opportunities present
Other RDRC/SHUR-related responsibilities as assigned; additional responsibilities at the mutual agreement of the supporting offices
Awareness of relevant governmental, professional, and institutional standards, policies, procedures, systems, requirements, and regulations; and demonstrated ability to apply them to complex scenarios
Excellent interpersonal skills and ability to interact with a wide variety of individuals with poise, patience, respect, and a customer service approach within regulatory and policy limitations; must be able to interact with faculty in a confident, professional, and diplomatic manner
Demonstrated ability to work independently with minimal oversight, exercise professional judgment in decision-making, and respond to challenges with flexibility, creativity, and poise
Proven written and oral communication and presentation skills
Exceptional organizational skills, including time-management, and the ability to multi-task and manage competing priorities
Demonstrated attention to detail, and strong analytical, record-keeping, tracking, and follow-up skills
Familiarity with relevant terminology (regulatory, biomedical, clinical, etc.) and typical research and clinical institutional oversight bodies (IRB, etc.); institutional systems (eResearch, etc.) desired
Facile with common workplace software applications (database, spreadsheet, word processing, presentations, etc.)
U-M Facilities and Operations (F&O) seeks to recruit and retain a diverse workforce as a reflection of our commitment to serve the diverse people of Michigan, to sustain the excellence of the university, and to offer our faculty, staff and students richly varied disciplines, perspectives, and ways of knowing and learning.
The University of Michigan conducts background checks on all job candidates upon acceptance of a contingent offer and may use a third party administrator to conduct background checks. Background checks are performed in compliance with the Fair Credit Reporting Act.
Job openings are posted for a minimum of seven calendar days. The review and selection process may begin as early as the eighth day after posting. This opening may be removed from posting boards and filled anytime after the minimum posting period has ended.
The University of Michigan is an equal opportunity/affirmative action employer.
U-M COVID-19 Vaccination Policy
COVID-19 vaccinations, including boosters when eligible, are required for all University of Michigan students, faculty and staff across all campuses, including Michigan Medicine. This includes those working remotely. More information on this new policy is available on the Campus Blueprint website or the UM-Dearborn and UM-Flint websites.
A great university is made so by its faculty and staff, and Michigan is recognized as one of the best universities to work for in the country. The Michigan culture is known for engaging faculty and staff in all facets of the university to create a workplace that is vibrant and stimulating.For two consecutive years, the Chronicle of Higher Education has placed U-M in its "Great Colleges to Work For" survey. In particular, the university earns high marks for strong relations between faculty and administrators, a collaborative system of governance, strong pay and benefits, and a healthy work/life balance.