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 Hematology/Oncology. The position is located at 1234 Kingshighway.
Position assists investigators as coordinator of moderately complex clinical research studies; may be responsible for multiple research studies simultaneously, acting as a liaison with the investigators, treating teams, IRB, sponsors, and sponsor agencies; responsible for managing and recording all aspects of study protocol requirements 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
Maintains regulatory record-keeping systems to organize and control the workflow as related to the hematology/oncology clinical trials
Maintains the current data management system
Acts as a resource for protocol related questions
Analyzes, investigates, and reports adverse events as needed
Makes decisions as when to notify supervisor, physicians and/or CRAs of issues, including recommending a halt to enrollment, consent revisions, consent signature requirements as well as when subjects require reconsent.� Monitors for protocol, IRB and federal compliance.
Resolves IRB/protocol management issues and recommends corrective action as appropriate
Serves as liaison between institutional investigators, Human Research Protection Office, Siteman Cancer Center, Cooperative Groups, Pharmaceutical Companies, Sponsoring Agencies, Center for Clinical Trials, NCI Central IRB (CIRB), and Clinical Trials Support Unit (CTSU)
Work with audit team to prepare for audits and assist during institutional site visits
Assist with timely submission of all protocol documentation including new study submission, modifications, continuing reviews and reportable events to the Human Research Protection Office, Protocol Review and Monitoring Committee, CIRB and CTSU.� Timely submission of all regulatory essential documentation to the sponsoring agencies.
Performs other duties as assigned.
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.
Preferred experience in Pediatrics and/or Oncology.
Working knowledge of computer programs and systems, with communication, organizational and interpersonal skills.
Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of database and spreadsheet management.
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.