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 OB/GYN.� The position is located at the Center for Outpatient Health.� This position is for the Medical School Campus.
Position provides regulatory support for multiple clinical research studies which may involve cooperative group studies, industry studies, and investigator initiated studies being conducted in the Division of Gynecologic Oncology.
PRIMARY DUTIES AND RESPONSIBILITIES:
Writes and prepares IRB regulatory submission, including, but not limited to, consent forms, new project applications, amendments, continuing review application, exceptions, and unanticipated problems.
Coordinates submissions to ancillary committees such as Protocol Review and Monitoring Committee, Radiation Safety Committee, and Institutional Biosafety Committee.
Serves as the primary regulatory contact for studies with internal and external groups. Maintains accurate records related to the regulatory aspects of research to ensure that regulatory files are audit-ready. Maintains compliance with regulatory requirements and institutional policies.
Collaborates with study investigators, nurses, study coordinators, and study sponsors to coordinate study start-up activities as well as ongoing activities. May coordinate timely investigator assessment of safety reports.
Proactively identifies regulatory issues and/or variances with study protocols and recommends process improvements.
Performs other duties incidental to the work described herein.
Bachelor’s degree required; prior work experience, preferably in clinical research support, is highly preferred; a combination of relevant work and education equaling four years may substitute for this requirement.
Prior work experience in an academic or pharmaceutical clinical trials environment.
IRB experience strongly desired.
Relevant certification such as CCRP.
Working knowledge of computer programs and systems.
Communication, organizational and interpersonal skills.
The hiring range for this position is $43,326 - $54,204 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.