Research Support - Laboratory/Non-Laboratory, Staff/Administrative
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 Neurology. The position is located at 4488 Forest Park. This position is for the Medical School Campus.
Position assists the DIAN Trials Unit (DIAN-TU) Cognition Core and Clinical Operations team with coordination of all aspects of cognitive assessments for a fast-paced and complex multi-site international clinical trial. The most critical aspects of the position include oversight of monitoring, scheduling, and communications with site raters and Home Health Nurses (HHNs).�
PRIMARY DUTIES AND RESPONSIBILITIES:
Assists Clinical Operations with tracking and scheduling of cognitive rater training and Quality Control reviews (QC) for all current and retrospective cognitive assessments for the DIAN-TU. Assists with clinical data management database lock and freeze activities. Facilitates support and communication between Clinical Operations, the Cognition Core and site coordinators, site raters, vendors, and Home Health Nurses (HHNs) at multiple international sites. Monitors and communicates with raters regarding completeness and accuracy of all cognitive assessment materials. Assists with internal metrics and tracking of QC and EDC verification activities. Ensures timely and accurate upload and entry of all materials related to cognitive data collection into electronic databases. Maintains and aids in the design of databases and materials for tracking compliance with rater training requirements.
Coordinates the preparation of Standard Operating Procedures (SOPs) source documents, QC documents, Rater materials, protocols, work instructions and other manuals specific to the cognitive data and its management. Coordinates development, circulation to sites and raters, and tracking of Corrective and Preventive Action forms (CAPAs). Reviews federal regulations to ensure compliance (e.g. ICH-GCP). Assists in audit related activities. Organization and proper filing of source documents related to cognitive assessments. Assists in study start-up and closing activities. Assists in the development and implementation of Cognitive data cleaning solutions.
Provides editing and QC of Cognitive Core cognitive assessment materials and manuals. Ensures raters and sites have proper materials and coordinates shipping and delivery of materials as needed. Accesses electronic databases to provide reports on archived data for QC purposes. Assists with DIAN-TU personnel training.
Performs other duties incidental to the work described herein.
Bachelor’s degree required; prior work experience, preferably in clinical research support, is highly preferred; a combination of relevant work and education equaling 4 years may substitute for this requirement.
ICH-GCP proficiency, CRA experience and practical experience in SOP and CRF development.
Working knowledge of techniques and methodologies used in developing, coordinating, and managing clinical research projects with working knowledge of database management and spreadsheets.
Good understanding of the operational execution of clinical protocols.
Basic business writing skills required for protocols amendments, study summaries, and progress reports.
Experience with various electronic data capture, web-based applications, and storage systems.
Excellent communication skills (both written and oral). Ability to be clear, direct, and tactful when communicating with multiple sites (national and international), departments, staff, CROs, vendors (e.g. Home Health Nurses), and investigators.
Willing to travel as necessary (i.e. investigator meetings, seminars or company meetings, etc.).
The hiring range for this position is $43,326 - $54,205 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.