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 Pediatrics, Division of Hematology & Oncology. This position is for the Medical School Campus.
Position assists investigators as coordinator of a complex clinical research study; may be responsible for multiple research studies simultaneously, acting as a liaison with the investigators, treating teams, pharmacy, laboratories, IRB, sponsors, and sponsor agencies; responsible for managing and recording all phases of study protocol as required by sponsoring agency to ensure compliance.
PRIMARY DUTIES AND RESPONSIBILITIES:
Routinely implements and manages all phases of study/protocol.
Ensures compliance with protocol guidelines and requirements of regulatory agencies
Establishes record-keeping systems and maintains a system of data collection by organizing and controlling the workflow as related to the hematology/oncology research patient activities
Makes assessments and determinations of participants’ progress in the study
Extracts data accurately from source documents and reports in various data entry systems within the protocol deadlines
Notifies appropriate personnel regarding ordering and administration of investigational agents
Analyzes, investigates, and reports adverse events
Makes decisions as when to notify physicians of issues, stop participant inclusion, and monitors for protocol compliance
Resolves IRB/protocol management issues and recommends corrective action as appropriate
Serves as liaison between institutional investigators, Human Research Protection Office, Operations Office, Siteman Cancer Center, Pharmaceutical Companies, Sponsoring Agencies, Center for Clinical Trials, and Patient Oriented Research Unit in Pediatrics
Works with audit team during institutional site visits
Ships research samples when needed
Assists with timely submission of all protocol documentation to the Human Research Protection Office and timely submission of all regulatory essential documentation to the sponsoring agencies.
Attends clinic and inpatient rounds to assist in study patient related concerns.
Performs other duties as assigned.
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.
Experience in pediatrics and/or oncology.
Experience with pharmaceutical sponsored protocols.
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.