Research Support - Laboratory/Non-Laboratory, Staff/Administrative
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.
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.
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:
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.
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.
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.
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.
Assist with coordination of Departmental scientific review of research protocols, in preparation for IRB submission.
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).
Perform monitoring of ongoing clinical studies, assuring appropriate procedures and compliance and that research projects are completed according to university and federal guidelines.
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.
Performs other duties incidental to the work described herein.
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.
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.
The hiring range for this position is $48,131 - $60,174 annually.
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.
Please attach a copy of your most current signed performance evaluation (completed within the last 18 months) to your online account. If you have not received a performance evaluation, you may provide two current signed letters of recommendation (written within the last 18 months), preferably to include one letter from either a current or recent former supervisor. To attach these documents, go to: My Career Tools, Add Attachment, Attachment Type – Performance Reviews or Letters of Recommendation.
Washington University in St. Louis, a medium-sized, independent university, is dedicated to challenging its faculty and students alike to seek new knowledge and greater understanding of an ever-changing, multicultural world. The University offers more than 90 programs and almost 1,500 courses leading to bachelor's, master's and doctoral degrees in a broad spectrum of traditional and interdisciplinary fields, with additional opportunities for minor concentrations and individualized programs. The faculty is composed of scholars, scientists, artists and members of the learned professions. They serve society by teaching; by adding to the store of human art, creativity, understanding, and wisdom; and by providing direct services, such as health care.