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 Center for Clinical Studies. The position is located at the Northwest Tower. This position is for the Medical School Campus.
Direct and coordinate all aspects of multi-center clinical research trials, which include tactical management, administration and leadership of project teams in order to ensure the project proceeds on time and within budget parameters.� Collaborates closely with the clinical trial principal investigator, external site investigators and staff, and other Washington University team members including those at Trial Care, the Center for Clinical Studies, and the Institute for Clinical and Translational Sciences.
PRIMARY DUTIES AND RESPONSIBILITIES:
Under general guidance and with latitude for the exercise of independent judgment and initiative:
Directs the planning, implementation and coordination of multi-center clinical trials sponsored by industry, government, non-profit foundations, or private organizations.� Coordinates the rapid assignment of new study protocols to local implementation experts for review. Tracks in a coordinated manner the IRB approval process, contract execution, ancillary approvals, credentialing requirements, and other study start-up requirements in partnership with study teams. Creates or assists in creating study documentation (e.g. SOPs, Manual of Study Operations, Case Report Form(s), source documents, surveys etc.) Provides input on the informatics-related components of study start-up. Prompts communications to ensure the shortest possible timeframes for start-up; and addresses questions from site investigators. Assists in budget development. Submits study protocol, consent form, and any subsequent amendments to the Institutional Review Board (IRB) of record and/or coordinate submission for a Single IRB review model.������������������������������������������������������������������
Develops quality assurance plan and provide ongoing monitoring of study performance, including data entry, inventory, recruitment, retention, and compliance with the protocol. Oversees the planning and implementation of the Investigator’s/Coordinators’ meeting. Interfaces with the Investigational Drug Service (IDS) to ensure proper distribution of study drug and placebo to each clinical site, if applicable. Oversees the development, collection and storage of regulatory documents required in clinical trial, e.g., FDA 1572, IRB approval, etc. Drafts requests and reports to regulatory agencies, e.g., IND application, annual IND update to FDA, etc. Reports Serious Adverse Experiences, other safety information, study suspension, etc. Tracks protocol deviations and develops Corrective Action Plans and tracking.�
Provides oversight and direction to study teams to ensure proper conduct in all aspects of a clinical trial being performed at each study site. Provides consultation and direction to study teams to resolve logistical problems associated with the research. Serves as liaison to study sponsors, clinical trial sites, pharmacy department, clinical and research laboratories, contract research organizations, study principal investigators, study medical monitors, biostatistics department, data management unit, and administration/fiscal unit, as needed. Plans internal meetings and provides professional direction within clinical trials coordination team.��������������������������������������������������������
Possesses extensive working knowledge of Good Clinical Practices (GCP) guidelines and Regulations applicable to study implementation and data management.
Bachelor of Science in Nursing (BSN) degree plus a minimum of 5 years direct experience in research related activities.
Current Missouri Nursing License.
Effective verbal, written and interpersonal communication skills
Demonstrated Microsoft office suite abilities
Effective working knowledge of grant compliance, clinical trial conduct, and FDA regulations preferred, accounting experience and familiarity with University systems preferred
Ability to take action in solving problems while exhibiting judgment and a realistic understanding of issues
Ability to organize or schedule people or tasks, to develop realistic plans while being sensitive to the needs of different constituencies, time constraints, and resource availability
Abilities with documenting activities, reading and interpreting written information such as federal, state, and internal guidelines and requirements
The hiring range for this position is $63,586 - $82,701 annually.
-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 G13.
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.