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.
Position oversees and coordinates complex or multi-site clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation and interaction with other departments. Prepares, maintains and assures regulatory compliance. Must have a strong working knowledge and experience in regulatory compliance, IRB processes and clinical research document audit/review.
PRIMARY DUTIES AND RESPONSIBILITIES:
Responsible for auditing and verification of data across multiple study types including investigator initiated, grant funded and industry sponsored trials.
Responsible for creating, maintaining and auditing study related regulatory documentation.
Ensures compliance to study protocol guidelines and requirements of regulatory agencies; identifies problems and/or inconsistencies and monitors participant’s progress to include documentation and reporting of adverse events; resolves IRB/protocol management issues and recommends corrective action as appropriate; serves as liaison with funding or sponsoring agency.
Provides guidance to members of research team in the implementation and evaluation of clinical research; trains new staff; will serve as lead and as point of reference for other research coordinators for questions, staff scheduling, and feedback on performance.
Maintains current knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Office of Human Research Protection (OHRP), and other regulatory guidelines.
Interacts with external monitors and QC reviewers as necessary.
Evaluates and interprets collected clinical data in conjunction with PI as appropriate.
Performs other duties incidental to the work described above.
Three years of clinical research coordinator experience with high degree of regulatory experience.
Bachelor’s degree in clinical research.
Ability to work closely and constructively with other departments and foster good working relationships with team and sites.
Commitment to support project, department, and institution Standard Operating Procedures (SOPs) and policies.
Ability to communicate effectively (written and oral).
Ability to manage time, multi-task, and effectively prioritize projects to meet timelines.
Strong work ethic.
Highly self-motivated, goal-oriented, and effective with minimal supervision.
Knowledge of and experience with Microsoft Word and Excel or similar computer programs.
Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with an emphasis on regulatory compliance and maintenance.
Bachelor’s degree plus a minimum of 3 years of clinical research experience with some level of lead or supervisory experience required; Master’s degree or a combination of work and education equaling 7 years may substitute for this requirement.
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location:
This position is in the Department of Radiology. The position is located at the East Building. This position is for the Medical School Campus.
The hiring range for this position is $56,472 - $72,010 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.