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 40 hours per week.
Department Name/Job Location:
This position is in the Department of Internal Medicine, Division of Geriatrics and Nutritional Science. The position is located at 660 S. Euclid Ave. This position is for the Medical School Campus.
The hiring range for this position is $54,267 - $69,201 annually.
Position oversees and coordinates complex or multi-site clinical research studies; serves as a resource to provide comprehensive information to clinical research staff by promoting a smooth operation, preparation of regulatory compliance and interaction with other departments; may supervise clinical research staff.
PRIMARY DUTIES AND RESPONSIBILITIES:
Directs the planning, implementation and coordination of multi-center clinical trials sponsored by industry, government or private organizations. Primary liaison to PI in developing plans for research projects and discussing the interpretation of results; collaborates in the preparation of manuscripts for publication and preparation of grant proposals to sponsoring agencies; assists in the preparation of amendments to protocols and/or modifications to study design as appropriate.
Plans internal meetings and provides professional direction for the Clinical Trials Coordinating Center (CCC) and/or clinical teams. Oversees the planning and implementation of Investigator’s/Coordinators’ meetings; responsible for meeting agendas and minutes. In collaboration with the PI, plans the study schedule and timelines. Assists in budget development.
Serves as a liaison to study investigators, site study coordinators and clinical staff, data coordinating center/data management core staff, the Central Investigational Review Board (cIRB); the Central Clinical Pharmacy and clinical trial site’s pharmacy departments, clinical and research laboratories, community health providers, community organizations, contract research organizations, study sponsors, and central administration/fiscal core.
With direction from the PI, drafts the study protocol, synopsis and schedule of activities, study operations manual; designs templates for source documentation used at clinical trial sites. Collaborates on the development and distribution of case report forms.
Oversees the development, collection and storage of regulatory documents required in clinical trial, e.g., FDA 1572, IRB approvals, etc. Drafts requests and reports to regulatory agencies, e.g., IND application, annual IND update to FDA, etc. Has extensive working knowledge of Good Clinical Practices (GCP) guidelines applicable to study implementation and data management. Assists in developing Standard Operating Procedures (SOPs). Is familiar with drug packaging designs.
Is responsible for organizing, tracking, and conducting training of clinical site coordinators; responsible for scheduling and conducting site initiation and site monitoring visits, and preparing related reports.
Is responsible for managing adverse event reporting for the study CCC. Receives from sites and reports notices of serious adverse experiences, protocol deviations, and study terminations, etc.
Serves as ex-officio member of the study Steering Committees and study sub-committees. Is responsible for organizing meetings of CCC sub-committees (recruitment, QC monitoring, etc.
Determines and conveys protocol clarifications to sites by phone, fax, email and memo.
Provides guidance to members of research staff in the implementation and evaluation of clinical trials; trains new staff; serves as CCC lead or as point of reference for other research coordinators for questions, staff scheduling, feedback on performance.
Evaluates and interprets collected clinical data in conjunction with PI as appropriate; prepares oral or written presentations or reports and analyses setting forth progress trends and provides recommendations or conclusions of the same.
Performs other duties incidental to the work described above.
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 -8 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
Med School HR website (medschoolhr.wustl.edu)
Internal Applicant Instruction:
This position is grade C12.
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.
Bachelor’s degree or Bachelor of Nursing degree, with major course works in appropriate health, social science, or biological science field and 3-5 years of experience in clinical research coordination; or an equivalent combination of education and experience. Master’s degree in a health-related field (MPH, MCI, MSN) preferred.
Knowledge of Good Clinical Practice, protocol planning, implementation, coordination, evaluation, and reporting of clinical trials.
Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of database management, spreadsheet and basic statistical analysis software. Proficiency with word-processing software.
Strong oral and writing skills, and attention to detail.
Bachelor’s degree plus a minimum of 3 years of clinical research experience with some level of lead or supervisory experience required; Master’s degree or a combination of work and education equaling 7 years may substitute for this requirement.
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 interdisciplin...ary 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.