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 Center for Clinical Studies. The position is located at Irene W Johnson Institute. This position is for the Medical School Campus.
Position oversees and coordinates complex clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation of clinical research; responsible for preparation of protocol related materials and regulatory submissions to federal agencies. Ensures regulatory compliance standards are maintained; may supervise clinical research staff.
PRIMARY DUTIES AND RESPONSIBILITIES:
Assists in protocol development for single and multisite clinical research studies, prepares and submits investigational drug and device applications to federal oversight agencies; provides a high level of direct and indirect support to Principal Investigator and research team.
Works in collaboration with the leadership at the Center for Clinical Studies to develop and maintain a robust Investigational Drug/Investigational Device program. This includes development of standardized processes and procedures that are compliant with FDA and ICH GCP requirements and development of best practices and educational offerings related to sponsor-investigator responsibilities.
Serves as a resource to the clinical research staff, ensuring appropriate procedures are followed, educates on policies and procedures; ensures that research projects are completed according to IRB and federal guidelines.
Develops and implements policies and procedures; provides comprehensive direction to clinical research personnel; may participate in training clinical research staff.
Provides Study Coordinator functions and performs all duties associated with the coordination and implementation of clinical research study/projects, data collection, and the management of data generated by study protocols.
Researches and recommends new methods and procedures to maintain standards and improve quality.
Bachelor of Science degree plus 4 years of clinical or research experience with at least 1 year of lead or supervisory experience included.
8 years of relevant education and work experience may substitute for this requirement.
Experience with monitoring clinical research for quality assurance purposes
Experience with FDA regulated clinical research, particularly research that requires an IND or IDE
Experience working directly with faculty members
Effective analytical and problem-solving skills.
Ability to communicate in oral and written form with all levels of personnel.
Ability to prioritize tasks in a diverse environment.
Must have demonstrated leadership and interpersonal skills.
The hiring range for this position is $60,840 - $77,584 annually.
Offers made for this position are contingent upon the successful completion of all required pre-employment screens, including a criminal background check, hair sample drug screen, and verification of required professional licenses, registrations, or certifications.
-Retirement Savings Plan -22 vacation days -10 Paid Holidays -Sick Time -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 -Other Benefits
HR website (hr.wustl.edu)
Internal Applicant Instruction:
This position is grade C13.
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.