Research - Laboratory/Non-Laboratory, Staff/Administrative
The Indiana University School of Medicine Department of Emergency Medicine is a statewide network of emergency departments striving to set new standards of training for medical students, residents, fellows and pre-hospital providers while providing quality care for a diverse patient population.
The Department of Emergency Medicine is seeking a candidate for the Network Regulatory Manager position. This position will act as liaison between research and clinical staff and the sponsors, IRB, federal, state and University officials and other regulatory agencies on topics related to research, compliance, IRB, finances and other post award administrative matters.
Ensure the continuing education for all staff as appropriate. This will include but is not limited to tracking CITI credentialing, ensuring completed COI, recommending advanced trainings for clinical research including biologics handling and bloodborne pathogen training, etc. Any and all trainings related to network studies should be tracked for completion and all records maintained across all potential network sites directly subcontracted with IUSM EM.
Act as a liaison between research and clinical staff and the sponsors, the IRB, federal, state, and university officials. This position will work closely with IUSM EM local research staff, to coordinate network studies both internal and external to IU. Many of these studies will have primary sites across the nation; this position will be responsible for ensuring local research implementation is meeting the standards and expectations of the primary site. All IRB responsibilities will be directly involved with the submission and maintenance of all regulatory documentation locally. All of these studies will be supported by an institution of the National Institutes of Health, so there will be federal reporting requirements regarding compliance, accrual rate, and data quality. Any additional reporting and monitoring will be on an as needed basis.
Maintain accurate communications of cost, policy changes, fiscal requirements, and other regulatory issues related to the networks. Each study introduced within the networks will have its own cost, policy, fiscal, and regulatory requirements. Ensuring that all of these different aspects are met and maintained throughout the duration of the program will be paramount to the success of the network. Serve as key, lead resource to research participants and collaborators.
Ensure compliance with all internal and external requirements of regulatory agencies. Responsible for ensuring all policies, procedures, and outcomes ensure compliance, exceptional service standards, and the successful operations of all network studies and collaborating sites. This not only includes the regulatory aspects described above, but also relates to ensuring the highest level of data quality across all sites and specific to each study. Monitoring studies across multiple sites will require a high degree of organization and attention to detail. Each site will present its own unique challenges and working efficiently and professionally to address any and all issues will ensure IUSM EM's compliance within each network and federal regulations related to the Common Rule.
Establish standard operating procedures for the implementation of studies both internal to IUSM EM and external to collaborating partners. These SOPs will create the foundation from which we maintain studies across multiple institutions that may not currently have research related policies but may subcontract with IUSM EM for any given network study.
Work in partnership with the federal funding agencies to ensure fiscal responsibility and goal attainment in all areas including budget, program development, compliance, and communications. For all locally established network studies, IUSM EM will be the primary site responsible for reporting financial activity for all sites across the network specific to those studies. For externally established SIREN studies (IU is not the lead site), IUSM EM will be responsible for tracking all subcontracted site financial activity and reporting all IUSM and subcontract financial data to the primary site. Collaborate with the IUSM EM Grants Coordination.
REQUIRED: Bachelor's degree and five years of experience in the areas of program administration, IRB, research compliance and/or contract and grant administration.
Combinations of related education and experience may be considered.
Understanding of contract and grant administration from pre- to post- award. Experience with multi center projects/sites. Work with government officials/external entities. Strong interpersonal skills, ability to take responsibility and resolve problems, demonstration of good decision making capabilities, ability to articulate complex situations and prioritize, have a high level of accuracy and attention to detail.
Master's degree or PhD. Six years of experience in the areas of program administration, IRB, research compliance and/or contract and grant administration.
Salary Plan: PAE
Salary Grade: 3RS
Campus: IUPUI - Indianapolis
Department: EMERGENCY MEDICINE (IN-EMER-IUINA)
Internal Number: 74954
About Indiana University
Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.