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.
The responsibility of the Project Manager is to 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.� To accomplish this, the Project Manager will collaborate 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.
Provides input on the informatics-related components of study start-up.
Prompts communications to ensure the shortest possible timeframes for start-up.
Addresses questions from site investigators.
Provides oversight and direction to study teams to ensure proper conduct in all aspects of a clinical trial being performed at each study site.
Creates or assists in creating study documentation (e.g. SOPs, Manual of Study Operations, Case Report Form(s), source documents, surveys etc.).
Provides consultation and direction to study teams to resolve logistical problems associated with the research.
Develops quality assurance plan and provides ongoing monitoring of study performance, including data entry, inventory, recruitment, retention, and compliance with the protocol.
Plans internal meetings and provides professional direction within clinical trials coordination team.
Oversees the planning and implementation of the Investigator’s/Coordinators’ meeting.
Assists in budget development.
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.
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.
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.
Possesses extensive working knowledge of Good Clinical Practices (GCP) guidelines and Regulations applicable to study implementation and data management.
Reports Serious Adverse Experiences, other safety information, study suspension, etc.
Tracks protocol deviations and develops Corrective Action Plans and tracking.
Interfaces with Central Lab to ensure proper distribution of lab kits and facilitate reporting of results to the appropriate individuals.
Interfaces with the Investigational Drug Service (IDS) to ensure proper distribution of study drug and placebo to each clinical site, if applicable.
Bachelor of Science in Nursing (BSN) degree plus a minimum of five years direct experience in research related activities.
REQUIRED LICENSURE/CERTIFICATION/REGISTRATION: Current Missouri Nursing License.
Registered Nurse degree preferred.
Knowledge of grant compliance, clinical trial conduct, and FDA regulations.
Accounting experience and familiarity with University systems.
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.
Ability to communicate verbally and in writing clearly and effectively, presenting ideas, documenting activities, reading and interpreting written information such as federal, state, and internal guidelines and requirements.
The hiring range for this position is $64,854 - $84,364 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.