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 for the Siteman Cancer Center. The position is located at the Center for Outpatient Health. This position is for the Medical School Campus.
Position coordinates and assists with the development, implementation, and regulatory compliance requirements of investigator-initiated research protocols for any investigator at the university submitting an oncology-based clinical trial. Assists Associate Director, Clinical Trials and faculty in developing documents to guide the conduct of investigator-initiated clinical research. Possesses detailed knowledge of protocol development, research operations, regulatory compliance, data collection mechanisms, and both internal and external policies and procedures regulating the conduct of clinical research.
PRIMARY DUTIES AND RESPONSIBILITIES:
Investigator-Initiated Protocol Management and Submission
Maintains and revises protocol-related documents, source documents, and data collection forms for investigator-initiated research protocols.
Maintains instruments, e.g. questionnaires, surveys, interviews, and assists with instrument validation.
Coordinates and participates in initial and ongoing protocol team meetings with appropriate investigators and staff, as needed.
Develops and submits amendment applications, including Protocol Review and Monitoring Committee (PRMC) Forms and Institutional Review Board (IRB) (known as the Human Research Protection Office, or HRPO) forms. Ensures that submissions comply with all applicable requirements (e.g. appropriate signoffs, forms, etc.), and communicates with investigators, research staff, and study sponsors (if applicable).
Revises study documents as per investigator suggestions and review committee requirements.
Performs Investigational New Drug (IND) application maintenance (including IND amendments and annual reports) to FDA and communicates with FDA as appropriate.
Assists investigators and research staff in complying with a broad range of applicable regulations and informs research personnel about new policies and procedures, answers questions, and finds solutions to problems.
Creates and maintains case report forms (CRFs) and specifically defined electronic databases for data collection for investigator-initiated protocols.
Maintains and manages electronic study files for investigator-initiated trials.
Develops clear timelines for data submission.
Reviews draft forms with study coordinator(s) to ensure feasibility and appropriateness of data plan.
Works with Associate Director to prioritize submissions based on established criteria.
Provides requested study-related information to investigators, study staff, PRMC, HRPO, FDA, study sponsors and other entities.
Maintains protocol-related records and performs additional administrative functions.
Prepares study-related reports for leadership.
Assists in implementation of policies and procedures for clinical trials operations and processes.
Participates in special projects as assigned.
Attends meetings and trainings as required.
Represent Protocol Development in meetings and presentations.
Ensures multi-center protocols include appropriate reporting, monitoring, and data capture language.
BS or BA degree with at least two years of experience in a research setting.
Thorough and demonstrable familiarity and expertise with the regulatory and operational side of clinical research, and the human subject protection system.
Understanding and familiarity with basic medical and research terminology.
Familiarity with oncology terminology a plus.
Investigator-initiated trial experience.
Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects and general principles of database management.
Familiarity with local and federal guidelines governing clinical trials.
Strong organizational and computer skills.
Ability to learn quickly and work independently and efficiently with minimal supervision.
Ability to independently prioritize tasks and to work under deadline pressure.
Excellent verbal and written communication skills.
Ability to interact effectively with a wide variety of individuals, including clinical investigators, regulatory and clinical research coordinators, administrative and support staff, representatives from pharmaceutical companies, and representatives from the FDA.
High attention to detail.
The hiring range for this position is $51,272 - $65,374 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.