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.
The Clinical Research Specialist (CRS) will work closely with the DIAN and DIAN-TU Cognition Core Leader, the Assistant Core Leader and other lab members and will be responsible for project management, vendor management, quality control and data verification processes, and ensuring that the Cognition Core follows ICH/GCP standards and additional regulatory requirements from protocol concept through study reporting. Ideally, the CRS will have experience with FDA regulated clinical trials and experience with cognitive and clinical assessment measures. DIAN and DIAN-TU are global studies with sites in EU, Asia, Australia, and North and South America. The position will involve maintaining frequent contact with raters and site coordinators at all DIAN and DIAN-TU sites as well as with project managers and other representatives from multiple vendors.
PRIMARY DUTIES AND RESPONSIBILITIES:
Quality Control: One of the primary functions of the Cog Core is to perform quality control reviews of cognitive assessments and verification that these reviews were completed correctly. Because the DIAN studies are global, we work with vendors with native language expert clinicians.
Vendor Management: The CRS will handle several aspects of vendor management including acquiring RFPs for competitive bids, assisting the Core members with contract negotiation and finalization, maintaining frequent contact with personnel from vendors including project managers, native language experts, and other vendor personnel.
Quality Control: Tracks QC processes with vendors and other core personnel to ensure timely completion.
QC verification: Ensures that QC processes are completed correctly and in accordance with Standard Operating Procedures (SOPs)
Manages a quality system to ensure compliance and to provide timely updates of data quality.
Maintains documentation and materials for Cog Core: Creates and maintains all Cog Core documentation. Maintains cognitive assessment battery materials and equipment and works with relevant cores from DIAN and DIAN-TU to ensure that materials are up to date and versioned appropriately for all DIAN sites globally. Works with vendors to manage eCOA assessments and equipment. Works with vendors, DIAN site personnel, and Cog Core personnel to acquire and update translations for each language used in DIAN studies.
Prepares and updates SOPs, work instructions, procedures manuals and other documents for the Cog Core.
Reviews federal regulations to ensure compliance (e.g. ICH-GCP).
Facilitates and responds to external and internal audits to ensure compliance with ICH-GCP and 21 CFR Part 11 compliance.
Acquires translations from vendors and manages clinician review of translations. Maintains translation certification documents.
Acquires and manages licenses from test publishers for proprietary cognitive measures.
Rater Management and Training: The CRS will be responsible for tracking and maintaining materials for a web-based rater training platform provided by a vendor. CRS will coordinate with Cog Core members and DIAN sites to track and maintain rater certification documents and procedures to ensure compliance with ICH/GCP standards.
Oversees acquisitions of translations of training content from vendors. Maintains translation certification documents.
Tracks all rater certification and manages notification system for certification expiration.
Schedules training webinars for raters and site coordinators.
Works closely with Cog Core leaders and Clinical Core personnel to facilitate critical study communications with raters and site coordinators.
Performs other duties incidental to the work described herein.
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.
Minimum of 5 years of regulated clinical trial (phase II/III) experience is essential.
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.
Working knowledge of database management.
Willing to ask for clarification or track down additional information independently.
Ability to establish workflows that comply with regulatory requirements.
At least a basic understanding of statistical analyses.
Experience working in culturally diverse environments is highly preferred.� Candidates must be committed to the School’s goal of advancing inclusive excellence and be prepared to explain how they have been and/or will be involved in advancing this goal within WUSM.
Experience with R, Python, or other data analysis software a plus.
Good understanding of the operational execution of clinical protocols.
Document development skills (e.g. formatting) in MS Word and Adobe Acrobat for protocol, procedure manual, rater script and other document development.
Basic business writing skills 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, software development teams), and investigators.
Applicant Special Instructions:
Able to travel as necessary (i.e. investigator meetings, seminars or vendor meetings, etc.).
The hiring range for this position is $62,067 - $79,144 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.