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Reference #: 23000899 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. The Clinical Research Coordinator, under the direction of the Director, CRORA and Clinical Investigators, will be responsible for the planning, implementation, and execution of Clinical Research studies in one or more departments in the Lewis Katz School of Medicine at Temple University. Incumbent will work independently to drive day to day research activities from study start-up to closeout. Primary responsibilities include: coordinate recruitment and enrollment of research participants; establish and maintain databases of subjects; schedule and conduct study visits; collect and enter data; register subjects and study visits in OnCore; perform Epic research billing review; maintain an up to date regulatory binder; schedule and attend sponsor visits; and prepare and submit IRB paperwork to ensure compliance with IRB regulations.  Incumbent may assist with grant or manuscript preparation and maintenance of investigator-initiated studies registered on clinicaltrials.gov. Incumbent may support multiple active protocols simultaneously, and working with multiple investigators while adhering with FDA, IRB, Pennsylvania, and related regulations. Performs other duties as assigned. to learn more about the benefits of working at Temple University. Required Education and Experience: Bachelor's degree in life science or health professions field and at least three years of directly related clinical research coordinator experience. An equivalent combination of education and experience may be considered. Required Skills and Abilities: *Prior experience with IRB submissions both local and central. *Strong eDC data entry skills. *Must have strong written and verbal communication skills with the ability to interact with a diverse population of students, faculty, staff, and program participants. *Ability to operate all standard office equipment/software including MS office. *Ability to work independently or as a team with attention to detail and adherence to project deadlines. *Knowledge of FDA, IRB, Pennsylvania and related regulations. Preferred: *Prior experience with IRB submissions both local and central. *Prior experience processing and shipping biological samples a plus *Prior phlebotomy certification or willing to learn a plus *Prior experience with RedCap, OnCore CTMS, Epic Research and Florence eBinders *Prior Electronic Data Capture (eDC) data entry skills. *Prior research experience in a healthcare setting *Prior research experience with NIH sponsored research studies, industry clinical trials, and investigator-initiated research studies. This position requires a background check. 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. In accordance with the City of Philadelphia's COVID-19 mandate, all Temple University students, faculty, staff, and contractors working in a healthcare setting must be fully vaccinated before receiving authorization to work unless they have a medical or religious exemption approved by the University.  An individual is considered fully vaccinated two (2) weeks following the second dose of the Pfizer or Moderna vaccine or two (2) weeks following a single dose of the Johnson & Johnson vaccine. Individuals who do not meet the University's vaccination or exemption requirement will be prohibited from working until proof of full vaccination or an exemption is requested and approved.  For more information, visit the University's Vaccines web page at https://www.temple.edu/coronavirus/vaccines. Compliance Stat ment: 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

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