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 OB/GYN. The position is located at the Center for Outpatient Health. This position is for the Medical School Campus.
Position assists investigators as coordinator of a complex clinical research study in Gynecologic Oncology; may be responsible for multiple research studies simultaneously, acting as a liaison with the school, sponsoring agency and the study participants; responsible for the collection, documentation, and reporting of clinical research and clinical trial data as required by sponsoring agency to ensure compliance.
PRIMARY DUTIES AND RESPONSIBILITIES:
Collects clinical data from study participants, medical records, interviews, questionnaires, diagnostic tests, and other sources under clinical research and clinical trial protocols. Ensures that relevant data from the source documents are abstracted and recorded in the CRFs and that every data point can be verified within the source document. Ensures validity of research results through timely, accurate, and complete data submission and query resolution.
Ensures compliance with protocol guidelines and requirements of regulatory agencies; monitors participants’ progress to include documentation and reporting of adverse events; reporting deviations, and recommending corrective action as appropriate.
Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Facilitates communication between the site and study sponsor, CRO, and/or regulators and exhibits teamwork skills necessary for managing the data collection and reporting process. May help train other Data Assistants within the Division.
Identifies and participates in complex problem solving related to data management. Provides data management expertise to the Research Manager and PIs in identifying opportunities for improvement. Works independently to develop and report on key data metrics and ensures timeliness of data and reporting for the Division’s research activities.
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.
Demonstrated ability to abstract subject data from medical record/source documentation and enter into case report forms and/or databases.
Experience resolving queries and/or monitoring.
Experience in research data management for clinical trials strongly preferred.
SOCRA OR ACRP certification.
Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of data 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.