Washington University of St. Louis Senior Protocol Development Coordinator - Siteman Cancer Center - 43391 in St. Louis, Missouri
This position is full-time and works approximately 40 hours per week.
Department Name/Job Location
This position is in 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 at a leadership level 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 Manager, 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:
New Investigator-Initiated Protocol Management and Submission:
- Develops protocol-related documents, source documents, and data collection forms for investigator-initiated research protocols.
- Develops instruments, e.g. questionnaires, surveys, interviews, and assists with instrument validation.
- Coordinates and participates in initial protocol team meetings with appropriate investigators and staff.
- Develops and submits new study 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 new 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.
- Submits Investigational New Drug (IND) applications 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 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.
- Work with PI and statisticians to ensure appropriate endpoints will be captured.
- Develop clear timelines for data submission.
- Review draft forms with study coordinator(s) to ensure feasibility and appropriateness of data plan.
- Review and revise data collection forms and electronic data capture system when needed.
- Work with Manager to prioritize submissions based on established criteria.
- Provides requested study-related information to investigators, study staff, PRMC, HSC, FDA, study sponsors and other entities.
- Maintains protocol-related records and performs additional administrative functions.
- Prepares study-related reports for management.
- 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 client 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 required.
- 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 $50,253 - $64,085 annually.
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.
Retirement Savings Plan
22 vacation days
8 Paid Holidays
Tuition benefits for employee, spouse and dependent children
Free Metro Link/ Bus pass
Free Life Insurance
Health, Dental, Vision
Health Savings Accounts (HSA)
Long Term Disability Insurance
Flex Spending Plan
Med School HR website (medschoolhr.wustl.edu)
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.
Job Title: Senior Protocol Development Coordinator - Siteman Cancer Center - 43391
Job ID: 43391
Location: Medical School
Full/Part Time: Full-Time