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. Please note the anticipated start date will be around July 1, 2021.
Department Name/Job Location:
This position is for the Siteman Cancer Center. The position is located at the Center for Outpatient Health. This position is for the Medical School Campus.
Position performs duties associated with the monitoring and auditing of clinical research studies involving review of data collection and the management of data generated by study protocols.
PRIMARY DUTIES AND RESPONSIBILITIES:
Conducts quality assurance reviews of SCC research trials, under the guidance of the Clinical Trials Manager and the Quality Assurance and Safety Monitoring Committee (QASMC). This includes working with QASM and Protocol Office staff to schedule audits with investigators, providing pre-audit instructions to study staff, auditing protocols, and writing draft audit findings letters.
Works with the study team in obtaining and reviewing data and safety monitoring (DSM) reports.
Reviews and summarizes Serious Adverse Event occurrences for review by the QASMC.
Performs follow-up interviews with data managers and Principal Investigators.
Prepares reports for QASMC.
Enters data into the SCC CTMS.
Assists with other tasks as assigned.
Bachelor’s degree in a related field or an equivalent level of training and experience.
Two years of experience in a clinical research setting.
Experience with oncology clinical trials is strongly preferred.
SOCRA or ACRP certification preferred.
Working knowledge of techniques and methodologies used in developing, coordinating and managing clinical research projects.
Demonstrated analytic skills.
Knowledge of institutional research systems and regulatory requirements, external agency guidelines (including FDA, OHRP), etc.
Working knowledge of standard office software, such as Microsoft Office.
Effective verbal, written and interpersonal communication skills.
The hiring range for this position is $51,272 - $65,374 annually.
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.
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.
Diversity strengthens our sense of community, and is vital to knowledge creation, problem solving and productivity — all of which are essential to the mission of Siteman Cancer Center. With this in mind, individuals with experience overcoming substantial educational, cultural or economic obstacles, are first-generation college students, and/or who can demonstrate a strong interest in bringing diverse people together are encouraged to apply for this position and will be highly regarded in the interview process.
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.