516226true516226falseSubmission for the position Regulatory Program Coordinator - Job Number 26000384false516226falsetrue
Regulatory Program Coordinator26000384 Temple Universitys Lewis Katz School of Medicines PulmCritical CareSleepMed Department is searching for a Regulatory Program Coordinator to join our team. Become a part of the Temple family and you will have access to the following:
Full medical dental vision coverage Paid time off 11 Paid Holidays Tuition remission - eligible employees and their dependents can obtain a degree TUITION FREE A generous retirement plan and so much more Salary Grade T25 Learn more about the T" salary structure. Salary Range 50000.00-55000.00 This role is also eligible for our employee referral program-TERP Current employees can earn up to 500 Conditions apply. Please contact the HR Employment office for details.
Job Details This position will be on-site This position requires the following background checks Cash Handling This is a grant funded position
Position Summary The Regulatory Program Coordinator under the supervision of the Regulatory Manager participates in the coordination of active Phase I-IV clinical trials and interacts with study sponsors PIs and research clinical staff in the Lewis Katz School of Medicines Thoracic Medicine & Surgery department.
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Required Education and Experience Bachelors degree and at least three years of experience in research and/or regulatory compliance in a research or clinical setting. An equivalent combination of education and experience may be considered.
Responsibilities Assists to maintain the oversight of all regulatory compliance monitoring including internal and external progress reports Prepares and processes all regulatory documentation through the IRB including new submissions continuing reviews amendments adverse events and reportable events Organizes and maintains all regulatory affairs documentation/files Supports compliance and quality assurance activities Participates in site visits monitoring audit and close out visits Participates in study team meetings other required group meetings and ongoing protocol training/compliance meetings Assists in the development of investigator-initiated protocols assists with IND applications and annual reports Assists with regulatory compliance guidance oversight of investigator initiated multi-center trials Trains research personnel on consent process/forms and the regulatory processes and regulatory documents. Performs other duties as assigned
Required Skills & Abilities Demonstrated knowledge and understanding of complex federal regulations ethical issues institutional policies and other federal agency requirements governing human subjects research. Demonated knowledge of quality assurance or auditing functions. Demonated computer skills and proficiency with MS Word MS PowerPoint MS Access or similar software programs. Excellent interpersonal and customer service skills along with the ability to effectively collaborate with a diverse constituent population. Excellent verbal and written communication skills including training skills. Demonstrated organizational and time management skills along with the ability to work under tight deadlines. Demonated ability to be detail-oriented. Demonated ability to work independently and as part of a team. Must maintain a working knowledge of current regulations guidelines and trends influencing the conduct of human subjects research. Ability to travel to off-site locations that may not be accessible via public transportation. Preferred Experience with biomedical human research is preferred.
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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.
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