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Reference #: 24000664 Description Grade: T25 The link below will give you information about the University's "T" salary structure. . A variety of important factors are reviewed by HR when considering salary, including job duties, the applicant's education and experience, all relevant internal equity considerations, department budget, and funding source. Summary: The Regulatory Coordinator will work under the supervision of the Sr. Manager, CRORA to prepare, submit, and maintain regulatory documents for investigators in the LKSOM. The Regulatory Coordinator will prepare submissions to the Temple IRB and external IRBs. In addition, the Regulatory Coordinator will create and manage study binders in the Florence electronic Trial Master File. The Lewis Katz School of Medicine at Temple University has experienced dramatic growth in the breadth and scope of its research enterprise over the past decade. As part of its strategic plan, our researchers and scientists have been responsible for ground-breaking advancements in areas across the scientific spectrum, including: Cancer Biology, Cardiovascular and Thrombosis, Cell and Developmental Biology, Clinical Lung Research, HIV, Immunology and Autoimmunity, Metabolic Syndrome and Diabetes, Neuroscience, Substance Abuse, Translational Medicine and more. Essential Functions: *  Prepare IRB submissions for investigators in LKSOM, including for initial reviews, continuing reviews, modifications, amendments, and study closures; *  Create and maintain study binders in the Florence eBinder system; *  Communicate with study teams to ensure study binders are kept up to date; *  Collect adverse event information to submit to the IRB; *  Assist research coordinator with preparation for monitoring visits; *  Participate as needed in sponsor visits, monitoring visits, audits, and inspections; *  Assist with the development of investigator-initiated protocols and study materials; *  Participates in study team meetings (in-person and virtual); *  Assists with IND and IDE submissions, annual progress reports; *  Assists with the development of source documents and guidance documents; *  Edit study documents in preparation for IRB submission, such as Informed Consent Forms, HIPAA Authorization, and other study-specific materials; *  Collect study team credentials (licenses, CVs) to maintain in study binders; *  Maintain documentation of correspondence and submissions to local and central IRBs; *  Keep up to date on IRB requirements. *  Works of special projects as needed *  Performs other duties as assigned. Benefits of working at Temple University include: Hybrid Work Arrangement Great Benefit package Generous time off Parental Leave Tuition Remission Dynamic Workforce At Temple, you will find it easy to fit in while staying true to yourself.  We value what makes each employee unique and strive to maintain a culture of diversity and inclusion.  As an employee, you will enjoy our collaborative team-based culture that values innovation and creativity. to learn more about the benefits of working at Temple University. Required Education & Experience: Bachelor's degree in a related field plus 3 years' related experience. An equivalent combination of education and experience may be considered. Required skills and abilities: *Must have strong written and verbal communication skills *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with excellent attention to detail and adherence to project deadlines. *Knowledge of FDA, IRB, Pennsylvania and related regulations. Preferred skills and abilities: *Prior experience with IRB submissions both local and central. *Prior experience with Florence eBinders *Prior IRB experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies. This position requires a background check. This is a grant-funded pos tion. This position is assigned a hybrid work arrangement (on-campus and remote), the duration of this hybrid work arrangement is at the discretion of Temple University and the Department. Temple University is committed to a policy of equal opportunity for all in every aspect of its operations, including employment, service, and educational programs. The University has pledged not to discriminate on the basis of age, color, disability, marital status, national origin or ethnic origin, race, religion, sex (including pregnancy), sexual orientation, gender identity, genetic information or veteran status. Compliance Statement: In the performance of their functions as detailed in the position description employees have an obligation to avoid ethical, legal, financial and other conflicts of interest to ensure that their actions and outside activities do not conflict with their primary employment responsibilities at the institution. Employees are also expected to understand and be in compliance with applicable laws, University and employment policies and regulations, including NCAA regulations for areas and departments which their essential functions cause them to interact. Temple University's Annual Security and Fire Safety Report contains statistics, policies, and procedures related to campus safety. . You may request a copy of the report by calling Temple University's Campus Safety Services at 215-204-7900.

Primary Location:Pennsylvania-Philadelphia-Health Sciences Campus (HSC)

Job:Staff Schedule:Full-time Shift:Day Job Employee Status:Regular

Temple University values diversity and is committed to equal opportunity for all persons regardless of age, color, disability, ethnicity, marital status, national origin, race, religion, sex, sexual orientation, veteran status or any other status protected by law.