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Washington University of St. Louis Clinical Research Coordinator II - Regulatory - Anesthesiology Clinical Research - 51874 in St. Louis, Missouri

Job Type/Schedule This position is full-time and works approximately 40 hours per week. Department Name/Job Location This position is in the Department of Anesthesiology Clinical Research. This position is for the Medical School Campus. Essential Functions POSITION SUMMARY: Position assists investigators as regulatory coordinator of multiple clinical research studies, acting as a liaison with the investigators, Institutional Review Board and industry sponsored, NIH funded, or investigator initiated clinical trials. PRIMARY DUTIES AND RESPONSIBILITIES: 1. Assists investigator in preparing study related essential documents in accordance with FDA regulations, ICH guidelines, Good Clinical Practice, and IRB requirements. Confers with PI to assist in developing plans for research projects; collaborates in the preparation of manuscripts for publications and preparation of grant proposals to sponsoring agencies; assists in the preparation & IRB submission of amendments to protocols and/or modifications to study design as appropriate. 2. Maintains study regulatory file system. Prepares documents for IRB approval; the protocol, IB, informed consent and all related patient forms, questionnaires, and advertisements; reviews journals, abstracts and scientific literature to keep abreast of new developments and to obtain information regarding previous studies to aid in the planning of new studies. 3. Works with Sponsors, Investigators, FDA and study staff to complete and submit new protocols and continuing protocol applications to the IRB. Routinely implements and manages all phases of study/protocol; ensures requirements of regulatory agencies; establishes record-keeping systems; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency. 4. Develop, prepare, and submit, in collaboration with investigators, FDA Investigational New Drug (IND) applications and Investigational Device Exemption (IDE) applications, and communicate with FDA as appropriate and requested by PIs. 5. Assist with coordination of Departmental scientific review of research protocols, in preparation for IRB submission. 6. Serve as a regulatory information (federal, state, institutional) resource along with the Manager of Clinical Research, for faculty and research staff, and as the communication and strategic interface between faculty investigators and institutional review board(s). 7. Perform monitoring of ongoing clinical studies, assuring appropriate procedures and compliance and that research projects are completed according to university and federal guidelines. 8. Assist investigators and research staff in complying with a broad range of applicable regulations and inform research personnel about new policies and procedures, answer questions, and find solutions to problems. 9. Performs other duties incidental to the work described herein. Required Qualifications Bachelor’s degree plus a minimum of two years of clinical research experience; a combination of relevant work and education equaling six years may substitute for this requirement. Preferred Qualifications * Previous work in a research regulatory environment. * Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of database management, spreadsheet and statistical analysis software. Salary Range The hiring range for this position is $48,131 - $60,174 annually. Pre-Employment Screening All external candidates receiving an offer for employment will be required to submit to pre-employment screening for this position. Current employees applying for a new position within the university may be subject to this requirement. The screenings will include a criminal background check and, as applicable for the position, other background checks, drug screen, employment and education or licensure/certification verification, physical examination, certain vaccinations and/or governmental registry checks. All offers are contingent upon successful completion of required screening. Benefits This position is eligible for full-time benefits. Please click the following link to view a summary of benefits: https://wustl.box.com/s/8wkhs25yssf0775x9d6nd6vqa7obpth7. EOE Statement Washington University is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, genetic information, disability, or protected veteran status. Job Title: Clinical Research Coordinator II - Regulatory - Anesthesiology Clinical Research - 51874 Job ID: 51874 Location: Medical School Full/Part Time: Full-Time Regular/Temporary: Regular