ResponsibilitiesUnder the direct supervision of the Clinical Trials Administrator, coordinate, and participate in all regulatory research activities as part of the Department of Urology. The incumbent will work with the PI, Sub-Investigators, research personnel and hospital staff (collectively, the Study Team) to develop and/or conduct both investigator-initiated and sponsor-initiated clinical trials and clinical research projects funded by industry-sponsors, federal and state agencies, and other non-profit foundations and organizations. Incumbent will be responsible for preparing, managing and submitting any required study/regulatory documents, and all required applications and forms, including but not limited to: submissions to the applicable Institutional Review Board (IRB), informed consent form development, required contractual and/or grant related documents, investigational pharmacy applications, other ancillary services applications, FDA IND/IDE/510k/SAE/MedWatch applications and submissions, etc. Incumbent must have strong analytical and problem solving skills to address and resolve potential issues as they arise. Work with study monitors to process, review and collect appropriate regulatory documents in a timely manner. Work flexible hours and/or overtime to meet study deadlines and requirements.
QualificationsClinical research experience as a Regulatory Coordinator in research involving human subjects. Working knowledge of FDA Good Clinical Practice and Good Laboratory Practice. Ability to work efficiently and complete tasks with a high degree of accuracy. Ability to effectively organize and manage multiple projects simultaneously. Strong analytical skills sufficient to work and problem solve with minimal supervision. Ability to multi-task and prioritize effectively. Ability to work flexible hours to accommodate research deadlines. Ability to concentrate and focus in a work environment that contains distracting stimuli and competing deadlines. Ability to be flexible and prioritize constantly shifting workload. Strong interpersonal communication skills to effectively and diplomatically interact with others. Strong written communication skills to compose correspondence. Strong computer skills and experience working with Microsoft Office Applications and able to perform the following tasks effectively: word processing, use and development of spreadsheets, e-mail and data entry (MAC, PC, MS WORD, MS EXCEL, MS OUTLOOK). Sufficient computer and computer networking knowledge sufficient to problem solve common hardware and software problems. Ability to handle confidential material with discretion in accordance with Federal, State, and local laws and regulations, and consistent with Institutional policies. Working knowledge of Institutional Review Board & Contracts and Grants policies and procedures. Demonstrated experience in writing research correspondence to IRB and study sponsors. Skill in coordinating diverse, complex tasks and information transfer among administrators, staff, committee members, and investigators. Ability to effectively respond and resolve sponsor queries, both written and verbal. Working knowledge of informed consent forms to ensure compliance with applicable laws and Institutional policies. Ability to track regulatory documents that include laboratory certification, CV's, IRB compliance and correspondence letters, medical licenses, FDA Form 1572, Delegation of Authority Forms, Serious Adverse Event submissions, MedWatch/IND submissions, etc. Ability to travel as required to attend meetings and conferences. Demonstrated ability to work effectively within a group as well as on independent projects. Demonstrated leadership skills to oversee research staff, delegate responsibilities, provide training, provide oversight of daily research activities, and participate in evaluation of performance standards.
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Internal Number: 63566801
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